EP3720385B1 - Medical implant delivery system - Google Patents
Medical implant delivery system Download PDFInfo
- Publication number
- EP3720385B1 EP3720385B1 EP18822226.9A EP18822226A EP3720385B1 EP 3720385 B1 EP3720385 B1 EP 3720385B1 EP 18822226 A EP18822226 A EP 18822226A EP 3720385 B1 EP3720385 B1 EP 3720385B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- frame
- implant
- attachment
- tack
- shaft
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
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Images
Classifications
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2230/0008—Rounded shapes, e.g. with rounded corners elliptical or oval
Definitions
- the present disclosure pertains generally, but not by way of limitation, to orthopedic implants and methods of treatment. More particularly, the present disclosure relates to a tendon repair implant, such as one that is engineered for arthroscopic placement over or in the area of a full or partial thickness tear of the supraspinatus tendon of the shoulder.
- a tendon repair implant such as one that is engineered for arthroscopic placement over or in the area of a full or partial thickness tear of the supraspinatus tendon of the shoulder.
- US 2017/189164 A1 relates to an example medical device.
- the medical device includes an implant delivery system having a delivery shaft including a proximal portion and a distal portion and a detachable frame coupled to the distal portion of the delivery shaft.
- the detachable frame includes a body portion and a plurality of attachment arms extending away from the body portion. The plurality of attachment arms is configured to be attached to an implant and the detachable frame is configured to detach from the delivery shaft in vivo.
- a tack member may extend through a portion of the frame.
- US 2004/220574 A1 relates to orthopedic devices.
- the devices include a part that is made of extracellular matrix material that has been hardened.
- One method of hardening the extracellular matrix is to comminute naturally occurring extracellular matrix and dry the comminuted material.
- the hardened extracellular matrix material can be machined to form a variety of orthopedic devices.
- US 5,261,914 relates to a surgical fastener for attaching soft tissues, e.g., a ligament to a bone.
- the surgical fastener comprises a shank and an enlarged head disposed on one end of the shank.
- a central bore passes completely through the fastener along its longitudinal axis, and a plurality of diametrically projecting ribs are disposed along the length of the shank.
- the invention relates to an implant delivery system as defined in the claims.
- An example implant delivery system includes a delivery shaft including a proximal portion, a distal portion and a lumen extending therebetween.
- the delivery system also includes a frame detachably coupled to the distal portion of the delivery shaft and a tack member coupled to the frame.
- tether member extends within the lumen of the delivery shaft.
- the frame includes a body portion and a plurality of attachment arms extending away from the body portion.
- tack member extends through an aperture in the body portion of the frame.
- a distal end portion of the tack member is configured to engage with a bone.
- retraction of the tether member is designed to disengage the tack member from a bone.
- distal end portion of the tack member includes a tapered region.
- a proximal end portion of the tack member includes a bore extending along a longitudinal axis of the tack member.
- the frame is configured to detach from the delivery shaft in vivo.
- tether is indirectly coupled to the frame via a connection member.
- the frame further comprises a first aperture configured to couple with the connection member.
- connection member includes a first profile and wherein the lumen of the delivery sheath includes a second profile, and wherein the first profile is configured to mate with the second profile.
- connection member is configured to disengage from the delivery shaft, and wherein the connection member is configured to remain engaged to the frame after disengaging from the delivery shaft.
- tack member can translate with respect to the connection member.
- the tack member includes a shaft having a circumferential surface and one or more protrusions extending radially away from the circumferential surface.
- the one or more curved protrusions are configured to anchor the tack member beneath a layer of bone.
- the tack member includes a shaft formed from a first material and one or more fixation members disposed along the shaft, wherein the one or more fixation members are formed from a second material different from the first material.
- the tether extends within the lumen of the delivery shaft while the delivery shaft is attached to the frame, and wherein the tether remains connected to the frame when the delivery shaft is detached from the frame.
- An example method for delivering an implant to repair a tendon includes advancing an implant repair system to a target site.
- the implant repair system includes a delivery shaft including a proximal portion and a distal portion, and a frame detachably coupled to the distal portion of the delivery shaft via a connection member.
- the frame includes a body portion and a plurality of attachment arms extending away from the body portion.
- a tack member is coupled to the connection member.
- An implant is attached to the attachment arms.
- the method further includes positioning the implant adjacent a bony structure of the target site and engaging the tack member with the bony structure. Thereafter, the delivery shaft is detached from the frame in vivo with the tack member remaining engaged with the bony structure. Thereafter, the implant is affixed to the target site.
- connection member is coupled between a distal end of the delivery shaft and the frame, and wherein detaching the delivery shaft from the frame includes disengaging the connection member from the distal end of the delivery shaft.
- engaging the tack member further includes anchoring the tack into the bony structure.
- the tack member includes a shaft having a circumferential surface and one or more curved protrusions extending radially away from the circumferential surface, and wherein anchoring the tack into the bony structure includes positioning the one or more curved portions beneath a cortical layer of bone.
- the tack member includes a shaft formed from a first material and one or more fixation members disposed along the shaft, wherein the one or more fixation members are formed from a second material different from the first material, and wherein anchoring the tack into the bony structure includes positioning the one or more fixation members adjacent a cortical layer of bone.
- the method further comprises withdrawing the frame from the target site after affixing the implant to the target site, and wherein withdrawing the frame from the target site includes retracting a tether coupled to the frame.
- references in the specification to "an embodiment”, “some embodiments”, “other embodiments”, etc. indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.
- a common soft tissue injury is damage to the rotator cuff or rotator cuff tendons.
- Damage to the rotator cuff is a potentially serious medical condition that may occur during hyperextension, from an acute traumatic tear or from overuse of the joint.
- Current repair procedures may attempt to alleviate impingement or make room for movement of the tendon to prevent further damage and relieve discomfort but do not repair or strengthen the tendon.
- An accepted treatment for rotator cuff tears may include reattaching the torn tendon to the humeral head using sutures. Additionally, in treating rotator cuff tears, an accepted practice may also include the placement of a scaffold over the repaired tendon to mechanically reinforce the repaired tendon. Therefore, there is an ongoing need to deliver and adequately position medical implants during an arthroscopic procedure in order to treat injuries to the rotator cuff, rotator cuff tendons, or other soft tissue or tendon injuries throughout a body.
- Figure 1 shows a cross-sectional view of a shoulder 10 including an example implant 12.
- Shoulder 10 further shows a head 14 of humerus 16 mating with a glenoid fossa 18 of scapula 20.
- the glenoid fossa 18 comprises a shallow depression in scapula 20.
- a supraspinatus tendon 22 is also shown. These muscles (along with others) control the movement of humerus 16 relative to scapula 20.
- a distal tendon 24 of supraspinatus tendon 22 meets humerus 16 at an insertion point 26.
- tendon 24 includes a damaged portion 28 located near insertion point 26.
- Damaged portion 28 includes a tear 30 extending partially through tendon 24.
- Tear 30 may be referred to as a partial thickness tear.
- the depicted partial thickness tear 30 is on the bursal side of the tendon, however, the tear may also be on the opposite or articular side of the tendon 24 and/or may include internal tears to the tendon 24 not visible on either surface.
- Figure 1 further illustrates that the tendon repair implant 12 has been placed over the partial thickness tear 30.
- the tendon repair implant 12 is placed on the bursal side of the tendon regardless of whether the tear is on the bursal side, articular side or within the tendon. Further, the tendon repair implant 12 may overlay multiple tears.
- delivery of an implant 12 may require a physician to create an incision in the patient sufficient to access the target implant site.
- the physician may insert an implant delivery system through the access site and position the distal end of the implant delivery system adjacent the target implant site. The physician may then manipulate the implant delivery system to deploy an implant out of a delivery sheath adjacent the target implant site.
- Figure 2 provides a perspective view of an implant delivery system 40 extending through the shoulder 10 of a patient.
- Figure 2 shows implant delivery system 40 deployed adjacent a target site (e.g., a tear in the supraspinatus tendon).
- implant delivery system 40 comprises a sheath member 42 (e.g., a cannula) including a proximal portion (not shown), a distal portion 48 and a lumen extending within at least a portion of cannula 42.
- implant delivery system 40 may include a delivery shaft 44 extending within the lumen of sheath member 42 and longitudinally movable relative thereto.
- Delivery shaft 44 may include a proximal portion (not shown) extending out of the proximal portion of sheath member 42 and/or otherwise manipulatable relative to sheath member 42 by a user. Additionally, in some examples the proximal portion of delivery shaft 44 and/or sheath member 44 may be coupled to a handle member (not shown). The handle member may be utilized to manipulate delivery shaft 44. For example, the handle member may be utilized to impart a rotational force to delivery shaft 44.
- delivery shaft 44 may include a distal portion 50 extending out of the distal portion 48 of sheath member 42. Further, delivery shaft 44 may include a lumen extending therein. The lumen of delivery shaft 44 may extend along a portion or the entire length delivery shaft 44 (e.g., from distal portion 50 to the proximal portion of delivery shaft 44).
- Delivery system 40 may further include a detachable frame member 46 attached to the distal portion 50 of the delivery shaft 44.
- detachable frame 46 may be attached to an implant 12 (e.g., a sheet-like implant).
- implant 12 e.g., a sheet-like implant
- the combined structure including frame 46 and implant 12 may be defined as having a proximal end 52 and a distal end 54 as illustrated in Figure 2 .
- a clinician may orient the frame 46 and implant 12 (for example, via a handle member attached to a proximal portion of the delivery shaft 44) such that the proximal portion 52 may be adjacent (e.g., overlaid) on a portion of the humerus (e.g., on the bone), while the distal portion 54 of the frame 46 and implant 12 may overlay the tendon 24.
- delivery of implant delivery system 40 may include the insertion of delivery sheath 42 through an access site (e.g., incision) and advancement to a target site.
- a clinician may deploy the detachable frame 46 in combination with the implant 12 out of the lumen located within and along the distal portion 48 of the delivery sheath 42, such as by retracting delivery sheath 42 relative to delivery shaft 44 and frame 46, and positioning implant 12 and frame 46 over the target site.
- the detachable frame 46 and implant 12 combination Prior to deployment, the detachable frame 46 and implant 12 combination may be contained (e.g., housed) within the lumen of delivery sheath 42 for subsequent deployment distally out distal opening of delivery sheath 42. As will be described in greater detail below, the combination of detachable frame 46 and implant 12 may wrap and/or fold upon itself such that it may be positioned within the lumen of the delivery sheath 42. Alternatively, detachable frame 46 and implant 12 may warp and/or fold around implant delivery shaft 44 while disposed within delivery sheath 42.
- FIG 3 shows an example detachable frame member 46 attached to example implant 12.
- detachable frame member 46 and implant 12 may have a proximal portion 52 which, for purposes of discussion herein, may be adjacent delivery shaft 44 and be configured to be positioned adjacent humerus 16.
- detachable frame member 46 and implant 12 may have a distal portion 54 which, for purposes of discussion herein, may extend away from deliver shaft 44 and be configured to be positioned adjacent tendon 24.
- Figure 3 further shows fastening regions 15 located at various positions within implant 12. As shown in Figure 3 , the fastening regions 15 are positioned at locations which are free from the structure of frame member 46. In other words, the shape of frame 46 may be designed to specifically permit fastening implant 12 to the anatomy at locations 15. For example, a clinician may staple implant 12 to the anatomy at locations 15.
- Figure 4A shows an example detachable frame member 46.
- frame member 46 may include a body portion 56.
- body portion 56 may be understood to define a circular, ovular, or similar shaped framework from which other members may extend.
- body portion 56 of frame 46 may bear some resemblance to an elongated oval having a proximal portion 52 and a distal portion 54.
- Body portion 56 may include one or more apertures 74.
- frame 46 may include a head portion 58 positioned within and/or extending away from the proximal portion 52. Head portion 52 may include an aperture 60.
- detachable frame 46 may include one or more attachment arms 64 extending away from body portion 56.
- Each respective attachment arm 64 may include a proximal portion 66 and a distal portion 68.
- the proximal portion 66 of each of the attachment arms 64 may be rigidly attached to body portion 56, while the distal portion 68 may be a free end of the attachment arm 64 spaced away from body portion 56.
- attachment arms 64 and head portion 58 may form a monolithic structure with body portion 56.
- body portion 56, head portion 58 and attachment arms 64 may be formed (e.g., machined, cut, shaped, stamped, laser-cut, etc.) as a unitary structure from a single piece of material.
- detachable frame 46 may be constructed using alternative materials and/or manufacturing methodologies.
- frame 46, or portions thereof may be constructed from a polymeric material, a ceramic material and/or other various materials.
- frame 46 may be manufactured via an injection molding or alternative polymer manufacturing methodologies.
- frame 46 may be formed through a 3-D printing process, if desired.
- attachment arms 64 may be made from a polymer material and combined with a central frame member constructed from a metal. Variations of combining different materials with different portions of frame 46 are contemplated.
- attachment arms 64 may include a variety of shapes.
- attachment arms 64 may include a bow and/or general curvilinear shape (such as that shown in the attachment arm 64 closest to head portion 58).
- an attachment arm 64 may include additional features, such as the circular portion 72 positioned along the attachment arm 64 (as shown in attachment arm 64 located farthest from head portion 58).
- the circular portion 72 may be designed to provide a "visual engagement marker" for which a user (e.g., clinician) may be able to engage a secondary medical device and manipulate the position of the frame 46 after initial deployment.
- a clinician may be able to engage a secondary medical device with circular portion 72 and thereafter manipulate the secondary medical device to alter the initial deployment position of frame 46.
- frame 46 may include a variety of shapes and/or geometric arrangements.
- frame 46 may include one or more stiffening members 62 extending throughout frame 46.
- stiffening members 62 may be arranged within frame 46 (e.g., within body portion 56) such that they create one or more apertures 74.
- the number, shape, configuration and/or arrangement of stiffening members 62 and/or apertures 74 may depend on the particular performance characteristics desired to be imparted to detachable frame 46.
- additional stiffening members 62 may be added to frame 46 to provide increased stiffness to frame 46.
- stiffening members 62 may take on particular geometries that increase stiffness or flexibility in a particular direction while decreasing stiffness or flexibility in a different direction, for example.
- Stiffening members 62 may be located (e.g., arranged) throughout frame 46 in a variety of configurations to provide additional stiffness and/or structural integrity to a particular frame shape. In other words, a wide variety of different shapes and/or arrangements of stiffening members 62 may be included within frame 46 in order to impart customized performance characteristics of frame 46. For example, in some instances, it may be desirable to transfer rotational forces placed on head portion 58 to attachment arms 64 positioned at the distal portion of frame 46. The addition of stiffening members 62 may allow transfer of those rotational forces throughout frame 46 (e.g., to the distal portion of frame 46) while minimizing the amount of force lost and/or dissipated throughout the frame due to undesirable flexing of the frame members.
- Figure 4B shows another example of the frame 46.
- frame 46 may include a geometric shape that is similar to that described with respect to frame 46 shown in Figure 4A .
- frame 46 may include stiffening members 62 extending and spaced in a different arrangement (as compared with the stiffening members 62 shown in Figure 4A ).
- the frame 46 shown in Figure 4B may include different apertures 74 created by the alternative arrangement of stiffening members 62.
- Figures 4A and 4B further illustrate that frame 46 may include one or more attachment apertures 70 located along a distal portion 68 of one or more attachment arms 64.
- Figures 4A / 4B show attachment apertures 70 positioned at a distal portion 68 of the attachment arms 64.
- attachment apertures 70 may be utilized to attach the frame 46 to an example implant 12.
- attachment apertures 70 may be located along another region of attachment arms 64, such as a proximal portion of attachment arms 64 proximate body portion 56. In other words, it is contemplated that one or more attachment arm apertures may be positioned along any portion of frame 46.
- Figure 4B shows two attachment apertures 70 positioned along a distal portion 68 of each of the attachment arms 64.
- the number of attachment apertures positioned along frame 46 may be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20 or more.
- attachment arms 64 may be devoid of attachment apertures. In such instances, attachment arms 64 may include an alternative attachment structure for attaching to implant 12.
- frame 46 when combined with an example implant 12, frame 46 may be defined as having a first surface that faces away from the implant 12 when implant 12 is attached to frame 46 (e.g., a first surface that faces away from a target site in the body) and a second surface that faces the example implant 12 (e.g., a second surface that faces a target site in the body).
- attachment apertures 70 may extend from the first surface to the second surface.
- attachment apertures 70 may be defined as holes and/or openings that extend through the thickness of frame 46 from the first surface of the frame 46 that faces away from the implant 12 to the second surface of the frame 46 that faces toward the implant 12.
- attachment apertures 70 may be utilized to attach and/or couple frame 46 to an example implant 12.
- Figure 5A shows an example frame 46 attached to an example implant 12.
- Figure 5 shows example frame 46 attached to example implant 12 at the distal or free end of each of the four attachment arms 64, respectively. Attachment of free distal ends of attachment arms 64 to implant 12 may be made by any desired attachment mechanism.
- Figure 5B shows a detailed view of a portion of the proximal portion 54 of a frame 46 attached to an implant 12 in a configuration similar to that discussed above with respect to Figures 2-4 . Further, Figure 5B shows example attachment arm 64 including a distal portion 68. Three attachment apertures 70 are positioned along the distal portion 68 of the attachment arm 64. Additionally, Figure 5B shows an example attachment member (e.g. wire) 76 extending between and through one or more of the attachment apertures 70 located on the distal portion 68 of attachment arms 64.
- example attachment member e.g. wire
- Attachment members 76 may be one of several structures and/or techniques contemplated to attach example frame 46 to example implant 12. As shown in Figure 5B , attachment member 76 may be positioned, looped, wound and/or threaded through one or more attachment apertures 70 such that the member 76 is prevented from being pulled away from the distal portion 68 of attachment arm 64. In other words, winding attachment member 76 through one or more attachment apertures 70 may effectively affix attachment member 76 onto the attachment arm 64.
- attachment member 76 may be affixed to the distal portion 68 of attachment arms 64 (via attachment apertures 70, for example) without having either end of the attachment member 76 directly attached (e.g., welded, tied, etc.) to any structure (e.g., frame 46). In some instances, member 76 may be wrapped and/or looped through attachment apertures 70 one or more times to provide a friction fit and/or resistive tension to unraveling or unwinding as a withdrawal force is applied to attachment member 76.
- Figure 5B shows a single attachment member 76 extending between two attachment apertures 70, it is contemplated that attachment member 76 may extend and/or wrap between two or more attachment apertures 70.
- attachment member 76 may be woven (e.g., over-and-under) through three apertures 70 in order to lock member 76 to the distal end 68 of attachment arm 64.
- an attachment member e.g., wire, thread, cable, etc.
- an attachment member e.g., wire, thread, cable, etc.
- adhesives may be used alone or in combination with another attachment mechanism to attach frame 46 to implant 12.
- injection molding techniques may be employed to attach frame 46 to implant 12.
- combinations of the disclosed techniques may be used to attach frame 46 to implant 12.
- an attachment member 76 may be used in conjunction with an adhesive to attach frame 46 to implant 12 without having to wind attachment member 76 through attachment apertures 70.
- frame 46 may be able to be "detached" from implant 12.
- frame 46 may be configured to detach from implant 12 after implant 12 has been affixed to a target site in the body, such as with staples and/or sutures. Therefore, it can be appreciated that in some examples disclosed herein, frame member 46 may be temporarily attached to implant 12.
- frame member 46 may be coupled, affixed or attached to implant 12 while positioned within delivery sheath 42, deployed out of delivery sheath 42 and maneuvered into position relative to a target site.
- implant 12 may be rigidly affixed to the target site, such as stapled and/or sutured to bone and/or tendon tissue at the target site.
- frame 46 may be pulled away (e.g., detached) from implant 12 and removed from the body.
- Figure 5B shows an example attachment configuration which may allow frame 46 to detach from implant 12.
- Figure 5B shows attachment member 76 wound in a spiral pattern 80 along the surface of implant 12 facing a target site.
- attachment member 76 may form a spiral pattern 80 that remains in a plane substantially parallel to the plane of the surface of implant 12 which faces a target site.
- attachment member 76 may extend from the side of attachment arm 64 facing away from implant 12, through the combined thickness of the attachment arm 64 and implant 12, eventually exiting implant 12 on the surface of implant 12 facing a target site.
- the spiral pattern 80 shown in Figure 5B is one of a variety of configurations for which attachment member 76 may be wound in order to prevent frame 46 from prematurely releasing from implant 12.
- Attachment member 76 may have a first end secured to a free distal end of attachment arm 64 positioned on a first side of implant 12 and have a second end positioned on a second, opposite side of implant 12. In some instances, attachment member 76 may extend through implant 12 from the first side of implant 12 to the second side of implant 12. However, in other instances, attachment member 76 may extend around an edge of implant 12 from the first side of implant 12 to the second side of implant 12.
- the attachment member 76 may be configured to be detached from implant 12 upon application of a threshold level of force.
- the spiral pattern 80 shown in Figure 5B may provide frame 46 the ability to detach from implant 12 when a force greater than or equal to a threshold "pull-away force" is applied to frame 46.
- a clinician may apply a force to frame 46 (via a tether, for example) such that frame 46 is pulled away from implant 12.
- attachment members 76 e.g., spiral portion 80 of attachment member 76 shown in Figures 5B
- body e.g., thickness
- attachment members 76 may be unwound and pulled back through the "body” (e.g., thickness) of implant 12, thereby releasing frame 46 from implant 12.
- the attachment member 76 forming the spiral 80 shown in Figure 5B may unwind and pull back through implant 12.
- the threshold "pull-away" force for the frame 46 to release from implant 12 may be about 0.25 lb to 1.75 lb, or may be about 0.75 lb to about 1.25 lb, or may be about 1.0 lb.
- the threshold "pull-away" force to release each of the four attachment member 76 from implant 12 may be about 0.0625 lb to 0.4375 lb, or may be about 0.1875 lb to about 0.3125 lb, or may be about 0.25 lb.
- Figure 5C shows another example method to attach frame 46 to an example implant 12.
- attachment member 76 may include a spiral 81 positioned on the surface of the implant 12 which faces away from a target site (similar to spiral 80 shown in Figure 5B ).
- Figure 5C shows that attachment member 76 may include a second spiral 82 positioned on the surface of attachment arm 68 that faces away from implant 12.
- Figure 5C shows two spirals 81/82 formed at opposite ends of attachment member 76 and positioned on both the attachment arm 64 facing away from implant 12 (e.g., spiral 82 of Figure 5C ) and on the side of the implant 12 lying along a treatment site (e.g., spiral 81 of Figure 5C ).
- the configuration of spirals 81/82 may provide a frame 46 with a "releasable" connection to implant 12 similar to that discussed with respect to Figure 5B .
- Figure 6 shows example frame 46 coupled to example implant 12 via attachment members 76 as described above. Further, Figure 6 shows frame 46 in combination with implant 12 coupled to example implant delivery system 40. Similar to that discussed with respect to Figure 2 , implant delivery system 40 includes implant delivery shaft 44 extending through an example lumen 84 of an example delivery sheath 42.
- connection assembly 88 may include a first connection member 90 attached to the head portion 58 of frame 46 and a second connection member 92 attached to the distal end 50 of delivery shaft 44. While Figure 6 does not directly show first connection member 90 attached directly to second connection member 92, it can be appreciated that the first and second connection members 90/92 of connection assembly 88 may form a mating connection.
- first connection member 90 may form a male connection member while second connection member 92 may form a mating female connection member.
- second connection member 92 may include a cavity which is configured to extend over and allow first connection member 90 to be inserted therein.
- the first connection member 90 may be a female connection member
- second connection member 92 may be a mating male connection member.
- connection assembly 88 may be defined as a "quick release" connection assembly, or otherwise decoupling connection assembly. It is further contemplated that a variety of design configurations may be employed to engage/disengage (i.e., couple/decouple) the first and second connection members 90/92 from one another.
- first and second connection members 90/92 may be coupled via a threaded connection, friction fit, spring loaded connection, bayonet connection, movable collar or other actuation mechanism, or the like. Further, connection member 90/92 may be engaged/disengaged by an operator of the device.
- delivery shaft 44 may be attached (via connection assembly 88, for example) to the head portion 58 of frame member 46.
- connection assembly 88 may attach to head portion 58 via an aperture 60 (shown in Figure 3 ).
- first connection member 90 may be attached to the head portion 58 of frame member 46 via a variety of mechanical fastening means (e.g., injection molding, encapsulation, bonding, etc.).
- delivery system 40 may include a tether 96 coupled to frame 46.
- Figure 6 shows tether 96 attached to first connection member 90.
- tether 96 may be coupled directly or indirectly to frame 46 and/or any other suitable structure.
- tether 96 may be a rigid structure (e.g., rod) or it may be a non-rigid structure (e.g., a wire, cable, etc.).
- tether 96 may be long enough to extend from frame 46 positioned at the target site to a location exterior of the patient through insertion site (i.e., incision), such as through a lumen 86 of delivery shaft 44 and out of a proximal portion of the implant delivery system 40 (e.g., proximal portion of delivery shaft 44).
- tether 96 may extend from frame 46 outside of delivery shaft 44 and out of a proximal portion of the implant delivery system 40.
- the tether 96 may be utilized to withdraw the frame 46 out of the body after the implant 12 has been attached.
- a physician may insert implant delivery system 40 (including a delivery sheath 42, delivery shaft 44, frame 46 and implant 12) through an incision and position the distal end of the implant delivery system 40 adjacent a target implant site (e.g., torn tendon).
- a target implant site e.g., torn tendon
- the physician may manipulate the implant delivery shaft 44 to advance the implant (while attached to the detachable frame 46) out of the delivery sheath 42 adjacent the target implant site.
- the physician may retract delivery sheath 42 proximally relative to delivery shaft 44 and frame 46 and/or may advance delivery shaft 44 and frame 46 distally relative to delivery sheath 42.
- Figure 6 shows frame 46 and implant 12 deployed from the distal portion 48 of delivery sheath 42.
- frame 46 and implant 12 may have a substantially concave shape with respect to delivery sheath 42. It can be appreciated that the concave shape of frame member 46 and implant 12 may facilitate positioning the implant 12 along the generally rounded shape of the human shoulder.
- frame 46 and implant 12 when positioned in the delivery sheath 42 (e.g., prior to deployment) the frame 46 and implant 12 may be wrapped around the delivery shaft 44 in a convex configuration. Therefore, frame 46 and implant 12 may shift from a first convex configuration (while wrapped tightly around delivery shaft 44 within lumen 84 of delivery sheath 42) to a second concave configuration when advanced (e.g., deployed) out of sheath 42.
- frame 46 and implant 12 may be attached to the delivery shaft 44 via the connection assembly 88 when positioned within the lumen 84 of the delivery sheath 42.
- the frame 46 and implant 12 may wrap, or extend around, the delivery shaft 44.
- the position of the frame 46 and implant 12 may be in a convex configuration with respect to the distal end 50 of the delivery shaft 44.
- the frame 46 and implant 12 may "shift" from a convex configuration to a concave configuration (as viewed with respect to the distal end 50 of delivery shaft 44).
- Figure 7 illustrates another example detachable frame member 146 attached to an implant 112. It is contemplated that any of the frame members and/or implants disclosed herein may be utilized in conjunction with any of the delivery systems and/or delivery system features disclosed herein. Further, frame member 146 and/or implant 112 may be similar in form and functionality to other example frame members described herein. For example, detachable frame member 146 and implant 112 may have a proximal portion 152 which, for purposes of discussion herein, may be adjacent delivery shaft 44 (described above) and be configured to be positioned adjacent humerus 16 (shown in Figure 1 ). Further, detachable frame member 146 and implant 112 may have a distal portion 154 which, for purposes of discussion herein, may extend away from deliver shaft 44 (described above) and be configured to be positioned adjacent tendon 24 (shown in Figure 1 ).
- Figure 8 shows example detachable frame member 146.
- frame member 146 may include a central body portion 156.
- body portion 156 may be understood to define a circular, ovular, square, rectangular or similar shaped framework from which other members may extend.
- body portion 156 of frame 146 may bear some resemblance to an elongated rectangle having a proximal portion 152 and a distal portion 154.
- Body portion 156 may include one or more apertures 174.
- frame 146 may include a head portion 158 positioned within and/or extending away from the body portion 156. Head portion 158 may include an aperture 160.
- detachable frame 146 may include one or more attachment arms 164 extending away from body portion 156.
- Each respective attachment arm 164 may include a proximal portion 166 and a distal portion 168.
- the proximal portion 166 of each of the attachment arms 164 may be rigidly attached to body portion 156, while the distal portion 168 may be a free end of the attachment arm 164 spaced away from body portion 156.
- attachment arms 164 and head portion 158 may form a monolithic structure with body portion 156.
- body portion 156, head portion 158 and attachment arms 164 may be formed (e.g., machined, cut, shaped, stamped, laser-cut, etc.) as a unitary structure from a single piece of material.
- detachable frame 146 may be constructed using alternative materials and/or manufacturing methodologies.
- frame 146, or portions thereof may be constructed from a polymeric material, a ceramic material and/or other various materials.
- frame 146 may be manufactured via an injection molding or alternative polymer manufacturing methodologies.
- frame 146 may be formed through a 3-D printing process, if desired.
- attachment arms 164 may be made from a polymer material and combined with a central frame member constructed from a metal. Variations of combining different materials with different portions of frame 146 are contemplated.
- attachment arms 164 may include a variety of shapes.
- attachment arms 164 may include a bow and/or general curvilinear shape (such as that shown in the attachment arm 164 closest to head portion 158).
- an attachment arm 164 may include additional features, such as the circular portion 172 positioned adjacent one or more attachment arms 164 (as shown adjacent two attachment arms 164 located farthest from head portion 158).
- the circular portion 172 may be designed to provide a "visual engagement marker" for which a user (e.g., clinician) may be able to engage a secondary medical device and manipulate the position of the frame 146 after initial deployment.
- a clinician may be able to engage a secondary medical device with circular portion 172 and thereafter manipulate the secondary medical device to alter the initial deployment position of frame 146.
- frame 146 may include a variety of shapes and/or geometric arrangements.
- frame 146 may include one or more stiffening members 162 extending throughout frame 146, such as throughout body portion 156.
- stiffening member 162 may be arranged within frame 146 (e.g., within body portion 156) such that it creates the one or more apertures 174.
- the number, shape, configuration and/or arrangement of stiffening members 162 and/or apertures 174 may depend on the particular performance characteristics desired to be imparted to detachable frame 146.
- stiffening members 162 may be added to frame 146 to provide increased stiffness to frame 146.
- stiffening members 162 may take on particular geometries that increase stiffness or flexibility in a particular direction and/or region while decreasing stiffness or flexibility in a different direction and/or region, for example.
- Stiffening members 162 may be located (e.g., arranged) throughout frame 146 in a variety of configurations to provide additional stiffness and/or structural integrity to a particular frame shape. In other words, a wide variety of different shapes and/or arrangements of stiffening members 162 may be included within frame 146 to impart customized performance characteristics on frame 146. For example, in some instances it may be desirable to transfer rotational forces placed on head portion 158 to attachment arms 164 positioned at the distal portion 154 of frame 146.
- stiffening members 162 may transfer those rotational forces throughout frame 146 (e.g., to the distal portion 154 of frame 146) while minimizing the amount of force lost and/or dissipated throughout the frame 146 due to undesirable flexing of the frame members.
- Figure 8 further illustrates that frame 146 may include an extension member 180 extending away from head portion 158 ("when viewed in the planar configuration shown in Figure 8 ).
- Extension member 180 may include a connection aperture 182 formed in a proximal region 184 of extension member 180.
- extension member 180 may include one or more extension arms 186 extending to a proximal portion of body portion 156.
- Extension arms 186 may be part of (e.g., a monolithic structure with) body portion 156.
- Figure 8 illustrates that extension arms 186 may include a curve.
- the shape of extension portion 180 may include a variety of shapes and/or configurations.
- Figure 8 further illustrates that frame 146 may include one or more attachment channels 170 located along a distal portion 168 of one or more attachment arms 164.
- Figure 8 shows attachment channels 170 positioned at a distal portion 168 of the attachment arms 164.
- attachment channels 170 may be utilized to attach the frame 146 to an example implant. While Figure 8 shows a single attachment channel 170 positioned along a distal portion 168 of each of the attachment arms 164, the illustrated number of attachment channels 170 is not intended to be limiting. In other words, it is contemplated that one or more attachment channels 170 may be positioned along any portion of frame 146.
- attachment channels 170 positioned along frame 146 may be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20 or more.
- attachment arms 164 may be devoid of attachment channels 170.
- attachment arms 164 may include an alternative attachment structure for attaching to an implant.
- frame 146 When combined with an example implant, frame 146 may be defined as having a first surface that faces away from the implant when the implant is attached to frame 146 (e.g., a first surface that faces away from a target site in the body) and a second surface that faces the example implant (e.g., a second surface that faces a target site in the body).
- attachment channels 170 may extend from the first surface to the second surface.
- attachment channels 170 may be defined as openings that extend through the thickness of frame 146 from the first surface of the frame 146 that faces away from the implant to the second surface of the frame 146 that faces toward the implant.
- attachment channels 170 may be utilized to attach and/or couple frame 146 to an example implant.
- Figure 9A shows an example frame 146 attached to an example implant 112. Further, Figure 9A shows example frame 146 attached to example implant 112 at the distal or free end of each of the four attachment arms 164, respectively. Attachment of free distal ends of attachment arms 164 to implant 112 may be made by any desired attachment mechanism.
- Figure 9A further illustrates locking covers 198 positioned along the distal portion 168 of attachment arms 164.
- Locking cover 190 may be used in conjunction with attachment channels 170 to secure frame 146 to implant 112.
- Locking covers 198 may be constructed of a variety of materials.
- locking covers 198 may include a metal, a polymer or combinations thereof, for example.
- Figure 9B shows a detailed view of a portion of frame 146 attached to an implant 112 in a configuration similar to that discussed above with respect to Figures 7 and 8 .
- Figure 9B shows example attachment arm 164 including a distal portion 168. Attachment channels 170 are positioned along the distal portion 168 of the attachment arm 164.
- Figure 9B shows an example attachment member (e.g. wire) 176 extending between and/or through one or more of the attachment channels 170 located on the distal portion 168 of attachment arms 164.
- example attachment member e.g. wire
- Attachment member 176 may include a variety of structures and/or techniques designed to attach example frame 146 to example implant 112. As shown in Figure 9B , attachment member 176 may be inserted, looped, wound and/or threaded through one or more attachment channels 170 such that the attachment member 176 is prevented from being pulled away from the distal portion 168 of attachment arm 164. In other words, sliding, inserting and/or winding attachment member 176 through one or more attachment channels 170 may effectively affix attachment member 176 to attachment arm 164.
- attachment member 176 may be affixed to the distal portion 168 of attachment arms 164 (via attachment channels 170, for example) without having either end of the attachment member 176 permanently attached (e.g., welded, etc.) to any structure (e.g., frame 146). In some instances, attachment member 176 may be wrapped and/or looped through attachment channel 170 one or more times to provide a friction fit, interference fit, and/or resistive tension to unraveling or unwinding as a withdrawal force is applied to attachment member 176.
- attachment channel 170 may include an opening that extends through the thickness of attachment arm 164 (e.g., from a top surface to the bottom surface of attachment arm 164) and also that attachment channel 170 may extend through the sidewall 171 of attachment arm 164 such that attachment member 176 may be laterally inserted into and/or removed from attachment channel 170. Additionally, attachment channel 170 may include one or more widths along the length of attachment channel 170. For example, Figure 9B shows attachment channel 170 including a first width "X" which extends through sidewall 171 of attachment arm 164.
- Attachment channel 170 further includes a second width "Y.”
- width "X” may be narrower than width "Y.”
- width "X” may be sized such that it is slightly smaller than the width (e.g., diameter) of attachment member 176.
- the general shape of attachment channel 170 may be designed such that it may flex to an extent sufficient to permit attachment member to extend (e.g., be inserted) through the narrower portion of channel 170 defined by the width "X” and further advanced into the wider portion of channel 170 defined by width "Y.”
- Figure 9B further illustrates example detents 173.
- Detents may extend inwardly from the surface of sidewall 171.
- detents 173 may be designed to mate with a protrusion or tab extending from an inner surface of locking member 198.
- detents may be protrusions or protuberances extending from the surface of attachment arm 164 configured to engage and/or mate with a feature of locking cover 198.
- Figure 9B shows an example attachment configuration which may allow frame 146 to detach from implant 112.
- Figure 9B shows a portion of attachment member 176 wound in a spiral pattern 180 along the surface of implant 112 facing a target site.
- attachment member 176 may form a spiral pattern 180 that remains in a plane substantially parallel to the plane of the surface of implant 112 which faces a target site.
- attachment member 176 may extend from the side of attachment arm 164 facing away from implant 112, through the combined thickness of the attachment arm 164 (e.g., via attachment channel 170) and implant 112, eventually exiting implant 112 on the surface of implant 112 facing a target site.
- the attachment member 176 may include a retention portion, such as a spiral pattern 180 positioned on the opposite side of implant 112 from attachment arm 164 for coupling implant 112 to attachment arm 164.
- a retention portion such as a spiral pattern 180 positioned on the opposite side of implant 112 from attachment arm 164 for coupling implant 112 to attachment arm 164.
- the spiral pattern 180 shown in Figure 9B is one of a variety of configurations for which attachment member 176 may be wound in order to prevent frame 146 from prematurely releasing from implant 112.
- the portion of attachment member 176 forming the spiral 180 shown in Figure 9B may unwind and/or straighten and pull back through implant 112.
- attachment member 176 may have another shaped configuration positioned on the surface of implant 112 facing a target site, which may be straightened or release upon a sufficient removal force to pull back through implant 112.
- Figure 9B further shows locking member 198 positioned along the distal portion 168 of attachment arm 164.
- locking member 198 may be able to translate (e.g., slide) along attachment arm 164.
- Figure 9B shows the distal portion 168 of attachment arm 164 extending through at least a portion of locking member 198.
- locking member 198 may be a sleeve in which attachment arm 164 extends through lumen of sleeve.
- locking member 198 is designed such that there is sufficient clearance between the inner surface (e.g., the inner diameter) of locking member 198 and the outer surface (e.g., the outer diameter) of attachment arm 164 such that locking member 198 can slide along attachment arm 164.
- locking member 198 may slide along attachment arm 164 to a position in which locking member 198 covers attachment member 176 and/or attachment channel 170.
- Figure 9C shows locking member 198 positioned at the distal end 168 of the attachment arm 164.
- Figure 9C shows locking member 198 positioned over the top (e.g., covering) of attachment member 176 and attachment channel 170. It can be appreciated that when positioned over the top of the attachment member 176 and/or attachment channel 170, locking member 198 may pinch, hold, secure, and/or lock attachment member 176 to attachment arm 164, such as by securing or locking attachment member 176 in attachment channel 170.
- locking member 198 may resemble a "compression-like" fitting wherein locking member 198 is drawn over the top of attachment member 176, thereby compressing attachment member 176 onto attachment arm 164 such that attachment member 176 is prevented from separating from attachment arm 164.
- locking member 198 may lock in place via detents 173.
- a feature of locking member 198 engages detents 173 to inhibit or prevent locking member 198 from moving back to the unsecured position shown in Figure 9B .
- the locking member 198 may include one or more inwardly projecting tabs (not shown) designed to be inserted (e.g., mate with) detents 173. The combination of tabs and detents 173 are, therefore, designed to prevent locking member 198 from moving along attachment arm 164 after having been positioned over top the attachment member 176 and/or attachment channel 170.
- attachment member 176 may be passed through implant 112 with distal enlarged portion (e.g., spiral 180) positioned on a second surface of implant 112 facing away from frame 146. Portion of attachment member 176 extending from a first surface of implant 112 facing frame 146 may then be passed through attachment channel 170, such as passed laterally into attachment channel 170 and then bent, wound or otherwise manipulated around attachment arm 164. Locking member 198 may then be moved from a first, unsecured position, shown in Figure 9B to a second, secured position, shown in Figure 9C to secure attachment member 176 to attachment arm 164.
- Figure 9D shows a detailed view of a portion of another example frame 246 attached to implant 112 in a configuration similar to that discussed above with respect to Figures 9A-9C .
- Figure 9D shows example attachment arm 264 including a distal portion 268.
- An attachment channel 270 is positioned along the distal portion 268 of the attachment arm 264.
- Figure 9D shows an example attachment member (e.g. wire) 276 extending through the attachment channel 270 located on the distal portion 268 of attachment arm 264.
- Figure 9D further illustrates that the distal portion 268 of the attachment arm 264 may include one or more openings 273 that extend through the thickness of attachment arm 264 (e.g., from a top surface to the bottom surface of attachment arm 264) and also that attachment channel 270 may extend through the sidewall 271 of attachment arm 264 such that attachment member 276 may be laterally inserted into and/or removed from attachment channel 270.
- attachment member 276 may be looped through one or more openings 273 and implant 112 (the dashed line in Figure 9D depicts the attachment member 276 being looped through implant 112) in addition to being secured within attachment channel 270.
- Attachment member 276 may include a variety of structures and/or techniques designed to attach example frame 246 to example implant 112. As shown in Figure 9D , attachment member 276 may be inserted, looped, wound and/or threaded through one or more attachment channels 270 and/or openings 273 such that the attachment member 276 is prevented from being pulled away from the distal portion 268 of attachment arm 264. In other words, sliding, inserting and/or winding attachment member 276 through one or more attachment channels 270 and/or openings 273 may effectively affix attachment member 276 to attachment arm 264.
- attachment member 276 may be affixed to the distal portion 268 of attachment arms 264 (via attachment channels 270 and/or openings 273, for example) without having either end of the attachment member 276 permanently attached (e.g., welded, etc.) to any structure (e.g., frame 246).
- attachment member 276 may be wrapped and/or looped through attachment channel 270 and/or openings 273 one or more times to provide a friction fit, interference fit, and/or resistive tension to unraveling or unwinding as a withdrawal force is applied to attachment member 276.
- Figure 9E illustrates that in some examples, a locking member 298 may be molded directly onto and/or otherwise positioned on the distal portion 268 of attachment arm 264.
- Figure 9E shows an example locking member 298 positioned along the distal portion 268 of the attachment arm 264 whereby the locking member 298 covers at least a portion of the attachment member 276 and/or attachment channel 270.
- Figure 9E shows locking member 298 encircling (e.g., covering) attachment member 276 and attachment channel 270.
- the locking member 298 may pinch, hold, secure, and/or lock attachment member 276 to attachment arm 264, such as by securing or locking attachment member 276 in attachment channel 270 and/or openings 273.
- locking member 298 may compress attachment member 276 onto attachment arm 264 such that attachment member 276 is prevented from separating from attachment arm 264.
- any of the examples described herein may utilize a sliding locking member 198 (as shown and described in Figures 9A-9C ) and/or an over-molded locking member 298 (as shown and described in Figure 9E ).
- Figure 10 illustrates a perspective view of frame 146 representing the configuration frame 146 would be in when inserted into the body.
- frame 146 shows frame 146 including extension member 180 coupled to both connection member 90 (similar in form and function to connection member 90 discussed above) and head portion 158.
- connection member 90 similar in form and function to connection member 90 discussed above
- head portion 158 may be coupled to connection member 90 and extend proximally therefrom.
- extension member 180 may curve upward and back on itself (e.g., upward and back toward the distal end 154 of frame 146).
- head portion 158 may extend upward and away from the body portion 156 of frame 146.
- connection member 90 may couple extension member 180 to head portion 158 via the apertures 182 and 160. In other words, connection member 90 may be inserted through both apertures 182 and 160, thereby securing extension member 180 to head portion 158. Additionally, Figure 10 shows a tack member 94 extending through a portion of frame 146. Tack member 94 will be described in greater detail below.
- Figure 10 illustrates that frame 146 may form a concave configuration when being inserted into the body. It can be appreciated that the concave shape of frame 146 may follow the contour of anatomy (e.g., shoulder) in which the example implant is to be secured.
- anatomy e.g., shoulder
- Figure 11 illustrates a side view of frame 146 described in Figure 10 .
- Figure 11 illustrates the concave shape of frame 146.
- Figure 11 shows extension member 180 curving upward and back toward distal portion 154 of frame 146 as described above.
- Figure 11 shows head portion 158 extending upward and away from body portion 156 of frame 146.
- Extension member 180 and the head portion 158 are coupled to one another via connection member 90 extending through connection apertures 182, 1 60.
- connection apertures 182, 160 may be coaxial, with connection member 90 extending therethrough.
- Figure 11 shows tack member 94 extending through a portion of frame 146, such that the distal tip of tack member 94 penetrates through implant 112 to be positioned a distance below the lower surface (the surface of implant 112 opposite the frame 146) of implant 112.
- Figure 11 further illustrates the tether member 96 described above with respect to Figure 10 .
- the tether member 96 may be coupled to the tack member 94. While the above discussion describes the tether member 96 indirectly coupled to frame member 146 via the connection member 90, it is contemplated that in other instances the tether member 96 may be directly coupled to frame 146 (or other similar frame members described herein).
- the configuration of frame 146 shown in Figures 7-11 may provide both precise control and maneuverability to a clinician or other operator of the medical device.
- the geometry of the extension member 180 in combination with head portion 158 and connection member 90 may provide precise maneuverability of the distal portion 154 of frame 146.
- an operator may manipulate connection member 90 with a delivery shaft 44 (described above).
- the delivery shaft may be able to impart a downward force (e.g., a force directed toward a patient's shoulder) onto frame 146 via the combination of connection member 190, extension member 180 and head portion 158.
- the concave geometry of frame 146 may allow the distal portion of frame 146 to extend along the surface of the shoulder for which the implant 112 is to be positioned.
- the geometry of frame 146 shown in Figure 10 and Figure 11 may prevent the distal portion 154 of frame 146 (including attachment arms 164) from pulling up and away from the shoulder surface as a clinician manipulates frame 146 within the body.
- the geometry of frame 146 shown in Figures 10 and 11 may allow the distal portion 154 of frame 146 to be advanced toward the surface of the shoulder in which an implant 112 is to be positioned.
- frame 146 shown in Figure 11 may allow a clinician improved visibility of the frame 146 (e.g., the distal portion 154 of frame 146) during implantation of the medical device.
- a clinician may position a camera adjacent the implantation site.
- the clinician may utilize the camera to accurately maneuver and/or position an example implant into the patient.
- the camera my obscure and/or impede the visibility of all or a portion of the frame or implant (e.g., frame 146 and/or implant 112).
- connection member 90 and delivery sheath 44 coupled to connection member 90
- angle ⁇ may be measured from a line 155 that is orthogonal to a line 151 tangent to a point 153 generally positioned at the apex of a curve defined by body portion 156.
- Orienting connection member 90 such that it is directed away from the distal end 154 of frame 146 may increase the amount of space for which a camera may be placed during a procedure. In other words, a clinician may be able to maneuver the camera such that it provides improved visibility of all or a portion of the medical device being implanted (e.g., implant 112 via frame 146).
- any of the implant delivery systems described herein may include a tack member designed to "anchor" the delivery system in place prior to a clinician affixing implant 12 to the bone and/or tendon.
- Figure 12A illustrates a tack member 94 extending distally from the first connection member 90.
- tack member 94 may extend distally from first connection member 90 and be substantially perpendicular to implant 12 and/or frame 46.
- tack member 94 may extend generally parallel to the longitudinal axis of delivery sheath 42 and/or delivery shaft 44 with the frame 46 and implant 12 extending generally perpendicular to the longitudinal axis of delivery sheath 42 and/or delivery shaft 44.
- this configuration is not intended to be limiting. Rather, it is contemplated that tack member 94 may extend distally from the first connection member 90 and/or frame 46 at an oblique angle to the longitudinal axis of delivery sheath 42, delivery shaft 44, and/or frame 46.
- tack member 94 may resemble a cylindrical pin or rod extending away from frame 46.
- the tack member 94 may be designed to be rigid enough to be pounded and/or inserted into bone.
- a clinician may apply a force to a proximal portion of the implant delivery system 40 (e.g., delivery shaft 44) such that tack member 94 may be "hammered" into a body structure (e.g., bone).
- tack member 94 may include a tapered distal tip, which may be a sharpened or blunt tapered distal tip in some instances.
- tack member 94 may be stationary (e.g., fixed in place) relative to frame 46 and/or first connection member 90 of connection assembly 88.
- tack member 94 may extend distally from first connection member 90 and away from the surface of frame 46 which faces a target site.
- tack member 94 While the above discussion describes example tack member 94, the discussion relative thereto is not intended to be limiting. Rather, a variety of tack member designs and configurations are contemplated herein. Different tack members may be designed to impart specific insertion forces while the tack is being driven into a body structure (e.g., bone). Additionally, these tack designs may also provide specific release forces upon removing the tack from a body structure (e.g., bone).
- Tack member 394 may include a proximal end region 340 and a distal end region 350.
- the distal end region 350 may include shaft member 352 and a tip member 354.
- the tip member 354. may be positioned at the distal end of the shaft member 352.
- the tack member 394 may include one or more radially enlarged portions positioned along the shaft member 352. Radially enlarged portions may be protuberances or lobes (e.g., continuous or discontinuous circumferential and/or helical rims, etc.) extending radially outward beyond the outer surface of the shaft member 352, for example.
- Figure 12B shows a first radially enlarged portion 356A and a second radially enlarged portion 356B positioned along the shaft member 352.
- the tack member 394 may include a single radially enlarged portion or more than two radially enlarged portions.
- the tack member 394 may include 1, 2, 3, 4, 5, 6, 7, 8 or more radially enlarged portions.
- the first radially enlarged portion 356A may be positioned adjacent tip member 354.
- the proximal end region 340 of the tack member 394 may include a vertical bore 355 extending inward from a proximal end surface 357 of the tack member 394.
- the vertical bore 355 may extend along the longitudinal axis 359 of the tack member 394.
- Figure 12B illustrates the tether member 96 (discussed with respect to Figure 12A ) extending within the vertical bore 355.
- the vertical bore 355 may include a profile which mirrors the shape of the tether member 96 extending within the vertical bore 355. It can further be appreciated that the tether member 96 may be attached to the tack member 394 via the vertical bore 355.
- the tether member 96 may be rigidly fixed to the tack member 394 within the vertical bore 355 via a variety of attachment techniques (e.g., welding, adhesive, crimping, swaging, etc.)
- the diameter of the tether member 96 is illustrated as being less than the diameter of the vertical bore 355, however, it is noted that upon securement of the tether member 96 within vertical bore 355, the tether member 96 may substantially occupy the bore 355.
- Figure 12B illustrates that the first radially enlarged portion 356A and the second radially enlarged portion 356B may be spaced longitudinally away from one another along the shaft member 352 with a portion of the shaft 352 positioned therebetween.
- Figure 12B shows the distance at which each of the first radially enlarged portion 356A and the second radially enlarged portion 356B are spaced away from the distal end 360 of the tip member 354.
- "X 1 " depicts the distance at which the first radially enlarged portion 356A is spaced away from the distal end 360 of the tip member 354.
- X 1 may be between 0.030 inches and 0.090 inches, or may be between 0.045 inches and 0.075 inches, or may be about 0.059 inches, for example.
- X 2 depicts the distance at which the second radially enlarged portion 356B is spaced away from the distal end 360 of the tip member 354.
- X 2 may be between 0.100 inches and 0.150 inches, or may be between 0.115 inches and 0.130 inches, or may be about 0.124 inches.
- first radially enlarged portion 356A and the second radially enlarged portion 356B may be adjacent one another.
- first radially enlarged portion 356A and the second radially enlarged portion 356B may be positioned directly adjacent one another.
- the tack member 394 may include more than two radially enlarged portions, some of which may be positioned away from other radially enlarged portions and/or some of which may be positioned directly adjacent other radially enlarged portions.
- first radially enlarged portion 356A and/or the second radially enlarged portion 356B may include a curved portion 357 having an outer surface which extends laterally away from the outer surface of the shaft member 352 located adjacent to the curved portion 357.
- the curved portion 357 of the radially enlarged portion 356 may have an outer diameter which is greater than the outer diameter of the shaft member 352 directly adjacent the curved portion 357.
- Figure 12B depicts the distance that curved portion 357 extends radially outward from the surface of the shaft member 352 as "X 3 .”
- X 3 may be between 0.001 inches and 0.015 inches, or may be between 0.005 inches and 0.010 inches, or may be about 0.006 inches.
- the distance that a first radially enlarged portion and a second radially enlarged portion extends away from the surface of the shaft member 352 may be different.
- a more proximal radially enlarged portion may extend radially outward from the shaft member 352 a greater distance or a lesser distance than a more distal radially enlarged portion.
- the distance that a first radially enlarged portion and a second radially enlarged portion extends away from the surface of the shaft member 352 may be substantially equivalent.
- the distance that curved portion 357 extends radially away from the surface of the shaft member 352 may correspond to the force required to retract the tack member 394 from a body structure into which the tack 394 may be inserted. It can further be appreciated that the shape, geometry, materials, etc. of the tack member 394 may be tailored to impart specific withdrawal forces from a body structure into which the tack member 394 may be inserted.
- the shaft member 352 may include a taper.
- the shaft member 352 may be tapered at an angle relative to the longitudinal axis 359 of the shaft member 352.
- angle of taper may be about 1 degree to about 5 degrees, for example.
- FIG 12C illustrates another example tack member 494.
- the tack member 494 may be similar in form and function to other tack members described herein.
- tack member 494 may include a proximal end region 440 and a distal end region 450.
- the distal end region 450 may include shaft member 452 and a tip member 454.
- the tip member 454 may be positioned at the distal end of the shaft member 452.
- the tack member 494 may further include the vertical bore 455.
- Figure 12C illustrates the tether member 96 extending within the vertical bore 455.
- the tether member 96 may be attached to the tack member 494 via the vertical bore 455 as described above.
- shaft member 452 may include one or more radially enlarged portions 462 positioned helically along the shaft member 452.
- the helical radially enlarged portion 462 may include a curved portion having an outer surface which extends radially outward beyond the outer surface of the shaft member 452.
- the helical radially enlarged portion 462 may extend longitudinally along the shaft member 452 in a helical fashion.
- Figure 12C shows a single helical radially enlarged portion extending along the surface of the shaft member 452, it is contemplated that the tack member 494 may include more than one helical radially enlarged portion 462.
- tack member 494 may include two helical radially enlarged portions helically arranged along the shaft member 452.
- first and second helical radially enlarged portions may extend around shaft member 452 in the same helical direction (e.g., a clockwise direction or a counterclockwise direction) along shaft member 452.
- first and second helical radially enlarged portions may extend around shaft member 452 in opposite directions (e.g., a first helical radially enlarged portion extending in a clockwise direction and a second helical radially enlarged portion may extend in a counterclockwise direction) along shaft member 452.
- FIG 12D illustrates another example tack member 594.
- the tack member 594 may be similar in form and function to other tack members described herein.
- tack member 594 may include a proximal end region 540 and a distal end region 550.
- the distal end region 550 may include shaft member 552 and a tip member 554.
- the tip member 554 may be positioned at the distal end of the shaft member 552.
- the tack member 594 may further include the vertical bore 555.
- Figure 12D illustrates the tether member 96 extending within the vertical bore 555.
- the tether member 96 may be attached to the tack member 594 via the vertical bore 555 as described above.
- tack member 594 may be formed as a composite structure including multiple components formed of dissimilar materials.
- tack member 594 may include shaft member 552 along with one or more fixation members 564 disposed along the shaft member 552 (depicted by the dashed line in Figure 12D ).
- the fixation members 564 may be constructed from materials different from the material used to construct the shaft member 552.
- the fixation members 564 may be formed from a material which is softer and/or more flexible than the material used to construct the shaft member 552, thus permitting the fixation members 564 to be radially compressible toward the longitudinal axis of the tack member 594.
- the fixation members 564 may include a polymeric material, composite material, or any other material with desirable compression/expansion characteristics, while the shaft member 552 may be formed of a metallic material, for example.
- the one or more fixation members 564 may surround or otherwise extend radially outward from the surface of the shaft member 552 with the shaft member 552 extending through the one or more fixation members 564.
- the one or more fixation members 564 may be positioned in one or more grooves or recesses formed in an outer surface of the shaft member 552.
- the fixation members 564 may be designed to provide a specific withdrawal force from a body structure into which the tack member may be inserted.
- the fixation members 564 may be designed from a material having a selected modulus which allows the material to be compressed while inserted into a body structure.
- this material may also permit the fixation members 564 to impart a specific radially-outward force against the body structure while inserted into the body structure. This radially-outward force may correspond to the force required to remove the tack member 594 from the body structure.
- radial compression of the fixation members 564 may be necessary for insertion of the tack member 594 into a body structure (e.g., bone) and removal of the tack member 594 from the body structure (e.g., bone).
- the materials, number, geometry, spacing, etc. utilized for the fixation members 564 may be tailored to provide a particular "release" force corresponding to a maximum threshold force that a clinician may want to impart on tack member 564 to remove it from the body structure.
- Tack member 694 may include a proximal end region 640 and a distal end region 650.
- the distal end region 650 may include shaft member 652 and a tip member 654.
- the tip member 654 may be positioned at the distal end of the shaft member 652.
- the tack member 694 may include one or more radially extending portions positioned along the shaft member 652. Radially extended portions may be protuberances (e.g., continuous or discontinuous circumferential and/or helical flats, etc.) extending radially outward beyond the outer surface of the shaft member 652, for example.
- Figure 12E shows a radially extending portion 653A positioned along the shaft member 652 and extending radially outward from the outer surface of shaft member 652. Additionally, Figure 12E shows a second radially extending portion 653B positioned adjacent to and/or extending from tip member 654.
- the tack member 694 may include a single radially extending portion or more than two radially extending portions.
- the tack member 694 may include 1, 2, 3, 4, 5, 6, 7, 8 or more radially extending portions.
- the first radially enlarged portion 652A may be positioned adjacent tip member 654.
- the proximal end region 640 of the tack member 694 may include a vertical bore 655 extending inward from a proximal end surface 657 of the tack member 694.
- the vertical bore 655 may extend along the longitudinal axis 659 of the tack member 694.
- Figure 12E illustrates the tether member 96 (discussed with respect to Figure 12A ) extending within the vertical bore 655.
- the vertical bore 655 may include a profile which mirrors the shape of the tether member 96 extending within the vertical bore 655. It can further be appreciated that the tether member 96 may be attached to the tack member 694 via the vertical bore 655.
- the tether member 96 may be rigidly fixed to the tack member 694 within the vertical bore 655 via a variety of attachment techniques (e.g., welding, adhesive, crimping, swaging, etc.)
- the diameter of the tether member 96 is illustrated as being less than the diameter of the vertical bore 655, however, it is noted that upon securement of the tether member 96 within vertical bore 655, the tether member 96 may substantially occupy the bore 655.
- Figure 12E illustrates that the first radially extending portion 653A and the second radially extending portion 653B may be spaced longitudinally away from one another along the shaft member 652 with a portion of the shaft 652 positioned therebetween.
- Figure 12E shows the distance at which each of the first radially extending portion 653A and the second radially enlarged portion 653B are spaced away from the distal end 660 of the tip member 654.
- "X 5 " depicts the distance at which the first radially extending portion 653A is spaced away from the distal end 660 of the tip member 654.
- X 5 may be between 0.090 inches and 0.175 inches, or may be between 0.115 inches and 0.150 inches, or may be about 0.127 inches, for example. Additionally, "X 4 " depicts the distance at which the second radially extending portion 653B is spaced away from the distal end 660 of the tip member 654. In some examples, X 4 may be between 0.025 inches and 0.100 inches, or may be between 0.050 inches and 0.075 inches, or may be about 0.062 inches.
- first radially extending portion 653A and the second radially enlarged portion 653B may be adjacent one another.
- first radially extending portion 653A and the second radially enlarged portion 653B may be positioned directly adjacent one another.
- the tack member 694 may include more than two radially extending portions, some of which may be positioned away from other radially extending portions and/or some of which may be positioned directly adjacent other radially extending portions.
- first radially enlarged portion 653A and/or the second radially enlarged portion 653B may include a rim or lip portion 651 having a radially extending tip 655 which extends laterally away from the outer surface of the shaft member 652.
- the radially extending portion 653A (including rim or lip portion 651) may have an outer diameter which is greater than the outer diameter of the shaft member 652.
- Figure 12E shows the diameter of the rim or lip portion 651 extending radially outward from the surface of the shaft member 652 as "D 2 " and the diameter of the shaft member 652 as "Dj.”
- D 2 may be between 0.035 inches and 0.100 inches, or may be between 0.050 inches and 0.075 inches, or may be about 0.070 inches.
- D 1 may be between 0.010 inches and 0.075 inches, or may be between 0.025 inches and 0.060 inches, or may be about 0.044 inches.
- the distance that a first radially extending portion 653A and second radially extending portion 653B extends away from the surface of the shaft member 652 may be different.
- a more proximal radially extending portion may extend radially outward from the shaft member 652 a greater distance or a lesser distance than a more distal radially extending portion.
- the distance that a first radially extending portion and a second radially extending portion extends away from the surface of the shaft member 652 may be substantially equivalent.
- the distance that radially extending portions 653A/653B extend radially away from the surface of the shaft member 652 may correspond to the force required to retract the tack member 694 from a body structure into which the tack 694 may be inserted. It can further be appreciated that the shape, geometry, materials, etc. of the tack member 694 may be tailored to impart specific withdrawal forces from a body structure into which the tack member 694 may be inserted.
- tack member 94 may be the first portion of delivery system 40 that exists the distal end 48 of delivery sheath 42 when the frame 46 and delivery shaft 44 are advanced out of the delivery sheath 42 upon deployment of the delivery system 40.
- the frame 46 to which implant 12 is attached
- a stationary tack member 94 may be fully housed within the lumen 84 of delivery sheath 48.
- the stationary tack member 94 may be driven directly into an adjacent structure (e.g., bone).
- frame member 46 and implant 12 may be positioned within delivery sheath 42 (depicted as dashed line) as shown in Figure 13A.
- Figure 13A shows frame member 46 (with implant 12) substantially aligned longitudinally with delivery shaft 44 and tack member 94.
- the distal portion 54 of frame 46 and implant 12 may be located distal of tack member 94 within delivery sheath 42, and thus the first portion of delivery system 40 that exits the distal end 48 of delivery sheath 42 when the frame 46 and delivery shaft 44 are advanced out of the delivery sheath 42 upon deployment of the delivery system 40.
- the frame member 146 and implant 112 may be positioned within delivery sheath 42 as shown in Figure 13B . Further, Figure 13B shows frame member 146 (and implant 112) substantially aligned longitudinally with delivery shaft 44 and tack member 94. In this example, the distal portion of frame 146 and implant 112 may be located distal of tack member 94 within delivery sheath 42, and thus the first portion of delivery system 140 that exits the distal end of delivery sheath 42 when the frame 146 and delivery shaft 44 are advanced out of the delivery sheath 42 upon deployment of the delivery system 40.
- Figure 13C illustrates that implant 112 may be rolled up and positioned between frame member 146 and the delivery sheath 42. Further, it can be appreciated that when positioned in delivery sheath 42 as illustrated in Figure 13B , implant 112 may wrap around frame member 146 with frame member 146 located radially inward of implant 112, and thereby extend along all or a portion of the inner surface of delivery sheath 42. Upon exiting the distal end of delivery sheath 42, implant 112 may unwrap to a configuration illustrated in Figure 10 and Figure 11 .
- tack member 94 may translate (e.g., slide, move, etc.) along a longitudinal axis within a lumen (not shown) of first connection member 90 of connection assembly 88.
- Figure 14 shows example deployment system 40 positioned adjacent an example target site.
- Figure 14 shows the proximal portion 52 of the frame 46 (along with implant 12) positioned adjacent the humeral head 16. In this position, the distal portion 54 of the frame 46 is positioned adjacent the tendon 24.
- Figure 14 further illustrates that the tack member 94 has not been advanced and/or extended out of the first connection member 90 of connection assembly 88 and driven into the humeral head.
- tack member 94 remains positioned within the connection assembly 88 (e.g., positioned within first connection member 90). However, in some examples contemplated herein, tack member 94 may be advanced out of the distal portion of delivery shaft 44 and/or connection assembly 88. In other words, the tack member 94 translates (e.g., slides, moves, etc.) relative to connection assembly 88 and advances away from the distal end 50 of delivery shaft 44.
- Figure 15 illustrates tack member 94 being advanced out of the distal portion 50 of delivery shaft 44 after delivery shaft 44 (along with frame 46 and implant 12) have been maneuvered and/or positioned adjacent an example target site.
- Figure 15 may depict delivery system 40 (discussed with respect to Figures 7 and 8 ) after the tack member 94 has been advanced out of the distal end 50 of the delivery shaft 44 (e.g., advanced distally of first connection member 90) and into the humeral head 16.
- tack member 94 may be advanced out of the distal end 50 of delivery shaft 44 via the application of a force at the proximal end of the delivery system 40 and/or actuation of an actuation mechanism to move tack member 94 relative to first connection member 90.
- a handle component may be utilized to generate a force to advance tack member 94 along a longitudinal axis of delivery shaft 44 and exit the distal end 50 of delivery shaft 44 distal of first connection member 90.
- FIG 15A illustrates the anchoring mechanism of the example tack member 394 (discussed above).
- the tack member 94 (of which tack member 394 shown in Figure 15A is a variation) may be anchored into the humeral head 16 of the humerus (a portion of which is shown in Figure 15A ).
- the humeral head 16 may include a cortical shell 17 covering a layer of soft bone 19.
- the cortical shell may be referred to as "hard" bone.
- Figure 15A further illustrates that in some instances it may be desirable to advance the tack member 394 through the layer of cortical bone such that the first radially enlarged portion 356A and/or the second radially enlarged portion 357A is positioned beneath the cortical bone layer.
- the tack member 394 may be advanced into the humeral head 16 such that the first radially enlarged portion 356A and/or the second radially enlarged portion 357A is positioned within the layer of soft bone, wherein the first radially enlarged portion 356A and/or the second radially enlarged portion 357A provide resistance to being pulled back through the underside of the cortical bone layer.
- first radially enlarged portion 356A and/or the second radially enlarged portion 357A are made of a compressible material
- the first radially enlarged portion 356A and/or the second radially enlarged portion 357A may be compressed as the first radially enlarged portion 356A and/or the second radially enlarged portion 357A are passed through the cortical shell 17.
- the amount of resistance provided by the first radially enlarged portion 356A and/or the second radially enlarged portion 357A may depend on the specific size and geometry of the first radially enlarged portion 356A and/or the second radially enlarged portion 357A.
- FIG. 16 illustrates removing delivery shaft 44 from the target site (depicted by the arrow in Figure 16 ) while the frame 46 and implant 12 remain anchored to the humeral head 16 via the tack member 94.
- delivery shaft 44 may be detached from frame 46 via uncoupling (e.g., detaching) second connection member 92 from first connection member 90.
- the bone e.g., humeral head
- tack member 94 may be abnormally soft or hard, and therefore, may require additional force to either maintain placement (e.g., if the bone is too soft) or to remove (e.g., if the bone is too hard). Therefore, a clinician may choose to reinsert and reengage shaft member 44 to frame 46 via re-coupling second connection member 92 to first connection member 90, such as after implant 12 has been attached to a target site via one or more bone and/or tendon staples, as described below.
- shaft member 44 may remain engaged to frame 46 while attaching implant 12 to a target site via one or more bone and/or tendon staples, as described below. The clinician may then be able to apply additional force to frame 46 and/or tack member 92 when attaching implant 12 to an example target site via one or more bone and/or tendon staples.
- delivery system 40 may include a tether 96 directly or indirectly coupled to frame 46.
- tether 96 may remain attached to frame 46 (e.g., via first connection member 90) and extend to a location exterior of the patient through insertion site (i.e., incision) with delivery shaft 44 detached from frame 46 and removed from insertion site (i.e., incision) while additional instruments are advanced through the insertion site and to the target site.
- Figure 17 shows a medical instrument 98 (e.g., implant stapler) positioned adjacent the proximal end 52 of the frame 46 and implant 12.
- a medical instrument 98 e.g., implant stapler
- tether 96 remains attached to frame 46 (e.g., via first connection member 90) and is positioned exterior of and alongside example medical instrument 98.
- the medical instrument 98 may be used to attach implant 12 to treatment site, such as with one or more, or a plurality of staples and/or sutures.
- implant 12 may be affixed to a target site after which the frame 46 may be detached (and removed) from both implant 12 and the target site.
- implant 12 may be attached to a target site via one or more bone and/or tendon staples.
- the staples may be applied to the target site via a stapling instrument (e.g., medical instrument 98).
- implant 12 it may be beneficial to affix implant 12 to the bone portion of the target site (e.g., humeral head 16) prior to affixing the implant to the tendon portion 24 of the target site.
- a clinician it may be beneficial for a clinician to orient and/or position the frame 46 and implant 12 in the location/arrangement shown in Figure 17 prior to affixing the implant to the target site.
- the implant is positioned such that the proximal portion 52 of the frame 46 and implant 12 are positioned adjacent the humeral head 16, while the distal portion 54 is positioned adjacent the tendon 24.
- a stapling instrument to first insert staples along the proximal portion 52 of the implant (e.g., the portion of the implant 12 positioned adjacent the bone) and into bone, followed by insertion of staples along the sides and distal portion of implant 12 and into tendon tissue.
- the tack member 94 may anchor the frame 46 and implant 12 in place (e.g., to the bone 16), thereby allowing a clinician to remove the delivery shaft 44 without fear that the frame/implant 46/12 combination will change position prior to the insertion of staples into the implant 12.
- the clinician may detach the frame 46 from the implant 12 (within the body) and remove it from the body via the insertion site.
- Figure 18 shows the detachment and removal of the frame 46 from the implant 12 (within the body) after the implant has been affixed (e.g., via staples) to the target site.
- the clinician may detach and remove frame 46 from the implant 12 and the body via application of a withdrawal force to the frame 46.
- the withdrawal force made be applied via the tether 96.
- a clinician may pull on the tether 96 (the proximal end of which may be positioned outside of the body), thereby applying a withdrawal force to frame 46. Once the withdrawal force reaches a threshold level (as discussed above), the frame 46 will detach from implant 12. Further withdrawal of the tether 96 may be continued to pull frame 46 out of the body via the insertion site.
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Description
- This application claims the benefit of
U.S. Provisional Patent Application Serial No. 62/595,737 filed on December 7, 2017 - The present disclosure pertains generally, but not by way of limitation, to orthopedic implants and methods of treatment. More particularly, the present disclosure relates to a tendon repair implant, such as one that is engineered for arthroscopic placement over or in the area of a full or partial thickness tear of the supraspinatus tendon of the shoulder.
- With its complexity, range of motion and extensive use, a common soft tissue injury is damage to the rotator cuff or rotator cuff tendons. Damage to the rotator cuff is a potentially serious medical condition that may occur during hyperextension, from an acute traumatic tear or from overuse of the joint. Adequate procedures do not exist for repairing a partial thickness tear of less than 50% in the supraspinatus tendon. Current procedures attempt to alleviate impingement or make room for movement of the tendon to prevent further damage and relieve discomfort but do not repair or strengthen the tendon. Use of the still damaged tendon can lead to further damage or injury. There is an ongoing need to deliver and adequately position medical implants during an arthroscopic procedure in order to treat injuries to the rotator cuff, rotator cuff tendons, or other soft tissue or tendon injuries throughout a body.
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US 2017/189164 A1 relates to an example medical device. The medical device includes an implant delivery system having a delivery shaft including a proximal portion and a distal portion and a detachable frame coupled to the distal portion of the delivery shaft. The detachable frame includes a body portion and a plurality of attachment arms extending away from the body portion. The plurality of attachment arms is configured to be attached to an implant and the detachable frame is configured to detach from the delivery shaft in vivo. A tack member may extend through a portion of the frame. -
US 2004/220574 A1 relates to orthopedic devices. The devices include a part that is made of extracellular matrix material that has been hardened. One method of hardening the extracellular matrix is to comminute naturally occurring extracellular matrix and dry the comminuted material. The hardened extracellular matrix material can be machined to form a variety of orthopedic devices. -
US 5,261,914 relates to a surgical fastener for attaching soft tissues, e.g., a ligament to a bone. The surgical fastener comprises a shank and an enlarged head disposed on one end of the shank. A central bore passes completely through the fastener along its longitudinal axis, and a plurality of diametrically projecting ribs are disposed along the length of the shank. - The invention relates to an implant delivery system as defined in the claims.
- This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An example implant delivery system includes a delivery shaft including a proximal portion, a distal portion and a lumen extending therebetween. The delivery system also includes a frame detachably coupled to the distal portion of the delivery shaft and a tack member coupled to the frame.
- Alternatively or additionally to any of the embodiments above, wherein further comprising a tether member coupled to a proximal portion of the tack member.
- Alternatively or additionally to any of the embodiments above, wherein the tether member extends within the lumen of the delivery shaft.
- Alternatively or additionally to any of the embodiments above, wherein the frame includes a body portion and a plurality of attachment arms extending away from the body portion.
- Alternatively or additionally to any of the embodiments above, wherein the tack member extends through an aperture in the body portion of the frame.
- Alternatively or additionally to any of the embodiments above, wherein a distal end portion of the tack member is configured to engage with a bone.
- Alternatively or additionally to any of the embodiments above, wherein retraction of the tether member is designed to disengage the tack member from a bone.
- Alternatively or additionally to any of the embodiments above, wherein the distal end portion of the tack member includes a tapered region.
- Alternatively or additionally to any of the embodiments above, wherein a proximal end portion of the tack member includes a bore extending along a longitudinal axis of the tack member.
- Alternatively or additionally to any of the embodiments above, wherein a distal end portion of the tether member is secured within the bore of the tack member.
- Alternatively or additionally to any of the embodiments above, wherein the plurality of attachment arms are configured to be attached to an implant.
- Alternatively or additionally to any of the embodiments above, wherein the frame is configured to detach from the delivery shaft in vivo.
- Alternatively or additionally to any of the embodiments above, wherein the tether is directly coupled to the frame.
- Alternatively or additionally to any of the embodiments above, wherein the tether is indirectly coupled to the frame via a connection member.
- Alternatively or additionally to any of the embodiments above, wherein the frame further comprises a first aperture configured to couple with the connection member.
- Alternatively or additionally to any of the embodiments above, wherein the connection member includes a first profile and wherein the lumen of the delivery sheath includes a second profile, and wherein the first profile is configured to mate with the second profile.
- Alternatively or additionally to any of the embodiments above, wherein the connection member is configured to disengage from the delivery shaft, and wherein the connection member is configured to remain engaged to the frame after disengaging from the delivery shaft.
- Alternatively or additionally to any of the embodiments above, wherein the tack member is stationary with respect to the connection member.
- Alternatively or additionally to any of the embodiments above, wherein the tack member can translate with respect to the connection member.
- Alternatively or additionally to any of the embodiments above, wherein the tack member includes a shaft having a circumferential surface and one or more protrusions extending radially away from the circumferential surface.
- Alternatively or additionally to any of the embodiments above, wherein the one or more curved protrusions are configured to anchor the tack member beneath a layer of bone.
- Alternatively or additionally to any of the embodiments above, wherein the one or more curved protrusions are spaced away from each other along the shaft.
- Alternatively or additionally to any of the embodiments above, wherein the tack member includes a shaft formed from a first material and one or more fixation members disposed along the shaft, wherein the one or more fixation members are formed from a second material different from the first material.
- Alternatively or additionally to any of the embodiments above, wherein the one or more fixation members extending radially away from a circumferential surface of the shaft.
- Alternatively or additionally to any of the embodiments above, wherein the tether extends within the lumen of the delivery shaft while the delivery shaft is attached to the frame, and wherein the tether remains connected to the frame when the delivery shaft is detached from the frame.
- An example method for delivering an implant to repair a tendon includes advancing an implant repair system to a target site. The implant repair system includes a delivery shaft including a proximal portion and a distal portion, and a frame detachably coupled to the distal portion of the delivery shaft via a connection member. The frame includes a body portion and a plurality of attachment arms extending away from the body portion. A tack member is coupled to the connection member. An implant is attached to the attachment arms. The method further includes positioning the implant adjacent a bony structure of the target site and engaging the tack member with the bony structure. Thereafter, the delivery shaft is detached from the frame in vivo with the tack member remaining engaged with the bony structure. Thereafter, the implant is affixed to the target site.
- Alternatively or additionally to any of the embodiments above, wherein the connection member is coupled between a distal end of the delivery shaft and the frame, and wherein detaching the delivery shaft from the frame includes disengaging the connection member from the distal end of the delivery shaft.
- Alternatively or additionally to any of the embodiments above, wherein engaging the tack member further includes anchoring the tack into the bony structure.
- Alternatively or additionally to any of the embodiments above, wherein the tack member includes a shaft having a circumferential surface and one or more curved protrusions extending radially away from the circumferential surface, and wherein anchoring the tack into the bony structure includes positioning the one or more curved portions beneath a cortical layer of bone.
- Alternatively or additionally to any of the embodiments above, wherein the tack member includes a shaft formed from a first material and one or more fixation members disposed along the shaft, wherein the one or more fixation members are formed from a second material different from the first material, and wherein anchoring the tack into the bony structure includes positioning the one or more fixation members adjacent a cortical layer of bone.
- Alternatively or additionally to any of the embodiments above, wherein the method further comprises withdrawing the frame from the target site after affixing the implant to the target site, and wherein withdrawing the frame from the target site includes retracting a tether coupled to the frame.
- The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.
- The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:
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Figure 1 illustrates a cross-section of an anterior view of a shoulder of a patient; -
Figure 2 illustrates a shoulder including a head of the humerus mating with the glenoid fossa of the scapula at a glenohumeral joint and an implant affixed to a tendon; -
Figure 3 illustrates an example implant delivery device attached to an implant; -
Figure 4A illustrates another example implant delivery device; -
Figure 4B illustrates another example implant delivery device; -
Figure 5A illustrates another example implant delivery device attached to an implant; -
Figure 5B illustrates an example delivery device attached to an implant; -
Figure 5C illustrates an example delivery device attached to an implant; -
Figure 6 illustrates another example implant delivery device; -
Figure 7 illustrates an example implant delivery device attached to an implant; -
Figure 8 illustrates another example implant delivery device; -
Figure 9A illustrates another example implant delivery device attached to an implant; -
Figure 9B illustrates an example delivery device attached to an implant; -
Figure 9C illustrates an example delivery device attached to an implant; -
Figure 9D illustrates an example delivery device attached to an implant; -
Figure 9E illustrates an example delivery device attached to an implant; -
Figure 10 illustrates another example implant delivery device; -
Figure 11 illustrates another example implant delivery device; -
Figure 12A illustrates a plan view of another example implant delivery device; -
Figure 12B illustrates a tack member to be used in the invention; -
Figure 12C illustrates another tack member to be used in the invention; -
Figure 12D illustrates another tack member to be used in the invention; -
Figure 12E illustrates another tack member to be used in the invention; -
Figure 13A illustrates a side view of another example implant delivery device with the sheath in cross-section; -
Figure 13B illustrates a side view of another example implant delivery device with the sheath in cross-section; -
Figure 13C illustrates an end view alongline 13C-13-C ofFigure 13B ; and -
Figures 14-18 illustrate an exemplary method of installing an implant with an example implant delivery device at a target site. - While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described.
- In this specifications the following non-SI units are used, which may be converted to the respective SI or metric unit according to the following conversion table:
Name of unit Symbol Conversion factor SI or metric unit Inch in 25.4 mm Pound lb 4.44822 N - For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
- All numeric values are herein assumed to be modified by the term "about", whether or not explicitly indicated. The term "about" generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the terms "about" may include numbers that are rounded to the nearest significant figure.
- The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
- As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.
- It is noted that references in the specification to "an embodiment", "some embodiments", "other embodiments", etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.
- The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure.
- With its complexity, range of motion and extensive use, a common soft tissue injury is damage to the rotator cuff or rotator cuff tendons. Damage to the rotator cuff is a potentially serious medical condition that may occur during hyperextension, from an acute traumatic tear or from overuse of the joint. Current repair procedures may attempt to alleviate impingement or make room for movement of the tendon to prevent further damage and relieve discomfort but do not repair or strengthen the tendon. An accepted treatment for rotator cuff tears may include reattaching the torn tendon to the humeral head using sutures. Additionally, in treating rotator cuff tears, an accepted practice may also include the placement of a scaffold over the repaired tendon to mechanically reinforce the repaired tendon. Therefore, there is an ongoing need to deliver and adequately position medical implants during an arthroscopic procedure in order to treat injuries to the rotator cuff, rotator cuff tendons, or other soft tissue or tendon injuries throughout a body.
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Figure 1 shows a cross-sectional view of ashoulder 10 including anexample implant 12.Shoulder 10 further shows ahead 14 ofhumerus 16 mating with aglenoid fossa 18 ofscapula 20. Theglenoid fossa 18 comprises a shallow depression inscapula 20. Asupraspinatus tendon 22 is also shown. These muscles (along with others) control the movement ofhumerus 16 relative toscapula 20. Adistal tendon 24 ofsupraspinatus tendon 22 meetshumerus 16 at aninsertion point 26. - In
Figure 1 ,tendon 24 includes a damagedportion 28 located nearinsertion point 26.Damaged portion 28 includes atear 30 extending partially throughtendon 24.Tear 30 may be referred to as a partial thickness tear. The depictedpartial thickness tear 30 is on the bursal side of the tendon, however, the tear may also be on the opposite or articular side of thetendon 24 and/or may include internal tears to thetendon 24 not visible on either surface. -
Figure 1 further illustrates that thetendon repair implant 12 has been placed over thepartial thickness tear 30. In this example, thetendon repair implant 12 is placed on the bursal side of the tendon regardless of whether the tear is on the bursal side, articular side or within the tendon. Further, thetendon repair implant 12 may overlay multiple tears. - In some instances, delivery of an implant 12 (e.g., a sheet-like implant) to a target site of a patient may require a physician to create an incision in the patient sufficient to access the target implant site. After creating this "access site," the physician may insert an implant delivery system through the access site and position the distal end of the implant delivery system adjacent the target implant site. The physician may then manipulate the implant delivery system to deploy an implant out of a delivery sheath adjacent the target implant site.
- For example,
Figure 2 provides a perspective view of animplant delivery system 40 extending through theshoulder 10 of a patient.Figure 2 showsimplant delivery system 40 deployed adjacent a target site (e.g., a tear in the supraspinatus tendon). In at least some embodiments,implant delivery system 40 comprises a sheath member 42 (e.g., a cannula) including a proximal portion (not shown), adistal portion 48 and a lumen extending within at least a portion ofcannula 42. Further,implant delivery system 40 may include adelivery shaft 44 extending within the lumen ofsheath member 42 and longitudinally movable relative thereto. -
Delivery shaft 44 may include a proximal portion (not shown) extending out of the proximal portion ofsheath member 42 and/or otherwise manipulatable relative tosheath member 42 by a user. Additionally, in some examples the proximal portion ofdelivery shaft 44 and/orsheath member 44 may be coupled to a handle member (not shown). The handle member may be utilized to manipulatedelivery shaft 44. For example, the handle member may be utilized to impart a rotational force todelivery shaft 44. - In addition,
delivery shaft 44 may include adistal portion 50 extending out of thedistal portion 48 ofsheath member 42. Further,delivery shaft 44 may include a lumen extending therein. The lumen ofdelivery shaft 44 may extend along a portion or the entire length delivery shaft 44 (e.g., fromdistal portion 50 to the proximal portion of delivery shaft 44). -
Delivery system 40 may further include adetachable frame member 46 attached to thedistal portion 50 of thedelivery shaft 44. As shown inFigure 2 ,detachable frame 46 may be attached to an implant 12 (e.g., a sheet-like implant). For purposes of the discussion herein, the combinedstructure including frame 46 andimplant 12 may be defined as having aproximal end 52 and adistal end 54 as illustrated inFigure 2 . - When initially positioning the
frame 46 andimplant 12 adjacent a target site, a clinician may orient theframe 46 and implant 12 (for example, via a handle member attached to a proximal portion of the delivery shaft 44) such that theproximal portion 52 may be adjacent (e.g., overlaid) on a portion of the humerus (e.g., on the bone), while thedistal portion 54 of theframe 46 andimplant 12 may overlay thetendon 24. - As described above, delivery of
implant delivery system 40 may include the insertion ofdelivery sheath 42 through an access site (e.g., incision) and advancement to a target site. After positioning thedistal end 48 ofdelivery sheath 42 proximate the target site, a clinician may deploy thedetachable frame 46 in combination with theimplant 12 out of the lumen located within and along thedistal portion 48 of thedelivery sheath 42, such as by retractingdelivery sheath 42 relative todelivery shaft 44 andframe 46, andpositioning implant 12 andframe 46 over the target site. - Prior to deployment, the
detachable frame 46 andimplant 12 combination may be contained (e.g., housed) within the lumen ofdelivery sheath 42 for subsequent deployment distally out distal opening ofdelivery sheath 42. As will be described in greater detail below, the combination ofdetachable frame 46 andimplant 12 may wrap and/or fold upon itself such that it may be positioned within the lumen of thedelivery sheath 42. Alternatively,detachable frame 46 andimplant 12 may warp and/or fold around implantdelivery shaft 44 while disposed withindelivery sheath 42. -
Figure 3 shows an exampledetachable frame member 46 attached toexample implant 12. As stated above with reference toFigure 2 ,detachable frame member 46 andimplant 12 may have aproximal portion 52 which, for purposes of discussion herein, may beadjacent delivery shaft 44 and be configured to be positionedadjacent humerus 16. Further,detachable frame member 46 andimplant 12 may have adistal portion 54 which, for purposes of discussion herein, may extend away from delivershaft 44 and be configured to be positionedadjacent tendon 24. -
Figure 3 further showsfastening regions 15 located at various positions withinimplant 12. As shown inFigure 3 , thefastening regions 15 are positioned at locations which are free from the structure offrame member 46. In other words, the shape offrame 46 may be designed to specifically permitfastening implant 12 to the anatomy atlocations 15. For example, a clinician may stapleimplant 12 to the anatomy atlocations 15. -
Figure 4A shows an exampledetachable frame member 46. As shown inFigure 4A ,frame member 46 may include abody portion 56. In some examples,body portion 56 may be understood to define a circular, ovular, or similar shaped framework from which other members may extend. For example,body portion 56 offrame 46 may bear some resemblance to an elongated oval having aproximal portion 52 and adistal portion 54.Body portion 56 may include one ormore apertures 74. Further,frame 46 may include ahead portion 58 positioned within and/or extending away from theproximal portion 52.Head portion 52 may include anaperture 60. - As shown in
Figure 4A ,detachable frame 46 may include one ormore attachment arms 64 extending away frombody portion 56. Eachrespective attachment arm 64 may include aproximal portion 66 and adistal portion 68. Theproximal portion 66 of each of theattachment arms 64 may be rigidly attached tobody portion 56, while thedistal portion 68 may be a free end of theattachment arm 64 spaced away frombody portion 56. In some examples (such as that shown inFigure 4A ),attachment arms 64 andhead portion 58 may form a monolithic structure withbody portion 56. In other words, in someexamples body portion 56,head portion 58 andattachment arms 64 may be formed (e.g., machined, cut, shaped, stamped, laser-cut, etc.) as a unitary structure from a single piece of material. However, the above discussion is not intended to be limiting. Rather, it is contemplated thatdetachable frame 46 may be constructed using alternative materials and/or manufacturing methodologies. For example,frame 46, or portions thereof, may be constructed from a polymeric material, a ceramic material and/or other various materials. Additionally,frame 46 may be manufactured via an injection molding or alternative polymer manufacturing methodologies. Alternatively,frame 46 may be formed through a 3-D printing process, if desired. Further, different portions of frame 46 (as described above, for example), may be made from a variety of materials and combined using alternative methodologies. For example,attachment arms 64 may be made from a polymer material and combined with a central frame member constructed from a metal. Variations of combining different materials with different portions offrame 46 are contemplated. -
Figure 4A further illustrates thatattachment arms 64 may include a variety of shapes. For example, in some instances,attachment arms 64 may include a bow and/or general curvilinear shape (such as that shown in theattachment arm 64 closest to head portion 58). In other examples, anattachment arm 64 may include additional features, such as thecircular portion 72 positioned along the attachment arm 64 (as shown inattachment arm 64 located farthest from head portion 58). In some instances, thecircular portion 72 may be designed to provide a "visual engagement marker" for which a user (e.g., clinician) may be able to engage a secondary medical device and manipulate the position of theframe 46 after initial deployment. In other words, a clinician may be able to engage a secondary medical device withcircular portion 72 and thereafter manipulate the secondary medical device to alter the initial deployment position offrame 46. - In some examples,
frame 46 may include a variety of shapes and/or geometric arrangements. For example, while the above discussion has focused on the shape offrame 46 shown inFigure 4A , it is not intended to be limiting. For example,frame 46 may include one ormore stiffening members 62 extending throughoutframe 46. Further, stiffeningmembers 62 may be arranged within frame 46 (e.g., within body portion 56) such that they create one ormore apertures 74. The number, shape, configuration and/or arrangement of stiffeningmembers 62 and/orapertures 74 may depend on the particular performance characteristics desired to be imparted todetachable frame 46. For example,additional stiffening members 62 may be added to frame 46 to provide increased stiffness to frame 46. In other instances, stiffeningmembers 62 may take on particular geometries that increase stiffness or flexibility in a particular direction while decreasing stiffness or flexibility in a different direction, for example. - Stiffening
members 62 may be located (e.g., arranged) throughoutframe 46 in a variety of configurations to provide additional stiffness and/or structural integrity to a particular frame shape. In other words, a wide variety of different shapes and/or arrangements of stiffeningmembers 62 may be included withinframe 46 in order to impart customized performance characteristics offrame 46. For example, in some instances, it may be desirable to transfer rotational forces placed onhead portion 58 toattachment arms 64 positioned at the distal portion offrame 46. The addition of stiffeningmembers 62 may allow transfer of those rotational forces throughout frame 46 (e.g., to the distal portion of frame 46) while minimizing the amount of force lost and/or dissipated throughout the frame due to undesirable flexing of the frame members. -
Figure 4B shows another example of theframe 46. For purposes of simplicity, the reference numerals depicted inFigure 4B may represent analogous elements described inFigure 4A . As shown inFigure 4B ,frame 46 may include a geometric shape that is similar to that described with respect to frame 46 shown inFigure 4A . However, as illustrated inFigure 4B ,frame 46 may include stiffeningmembers 62 extending and spaced in a different arrangement (as compared with the stiffeningmembers 62 shown inFigure 4A ). Additionally, theframe 46 shown inFigure 4B may includedifferent apertures 74 created by the alternative arrangement of stiffeningmembers 62. -
Figures 4A and4B further illustrate thatframe 46 may include one ormore attachment apertures 70 located along adistal portion 68 of one ormore attachment arms 64. For example,Figures 4A /4B show attachment apertures 70 positioned at adistal portion 68 of theattachment arms 64. As will be discussed in greater detail below,attachment apertures 70 may be utilized to attach theframe 46 to anexample implant 12. - While
Figure 4A shows threeattachment apertures 70 positioned along adistal portion 68 of each of theattachment arms 64, the illustrated number ofattachment apertures 70 is not intended to be limiting. In other embodiments,attachment apertures 70 may be located along another region ofattachment arms 64, such as a proximal portion ofattachment arms 64proximate body portion 56. In other words, it is contemplated that one or more attachment arm apertures may be positioned along any portion offrame 46. For example,Figure 4B shows twoattachment apertures 70 positioned along adistal portion 68 of each of theattachment arms 64. The number of attachment apertures positioned alongframe 46 may be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20 or more. In other instances,attachment arms 64 may be devoid of attachment apertures. In such instances,attachment arms 64 may include an alternative attachment structure for attaching to implant 12. - For simplicity purposes, when combined with an
example implant 12,frame 46 may be defined as having a first surface that faces away from theimplant 12 whenimplant 12 is attached to frame 46 (e.g., a first surface that faces away from a target site in the body) and a second surface that faces the example implant 12 (e.g., a second surface that faces a target site in the body). In some instances,attachment apertures 70 may extend from the first surface to the second surface. In other words, in some instances,attachment apertures 70 may be defined as holes and/or openings that extend through the thickness offrame 46 from the first surface of theframe 46 that faces away from theimplant 12 to the second surface of theframe 46 that faces toward theimplant 12. - As stated above,
attachment apertures 70 may be utilized to attach and/orcouple frame 46 to anexample implant 12.Figure 5A shows anexample frame 46 attached to anexample implant 12. Further,Figure 5 showsexample frame 46 attached toexample implant 12 at the distal or free end of each of the fourattachment arms 64, respectively. Attachment of free distal ends ofattachment arms 64 to implant 12 may be made by any desired attachment mechanism. -
Figure 5B shows a detailed view of a portion of theproximal portion 54 of aframe 46 attached to animplant 12 in a configuration similar to that discussed above with respect toFigures 2-4 . Further,Figure 5B showsexample attachment arm 64 including adistal portion 68. Threeattachment apertures 70 are positioned along thedistal portion 68 of theattachment arm 64. Additionally,Figure 5B shows an example attachment member (e.g. wire) 76 extending between and through one or more of theattachment apertures 70 located on thedistal portion 68 ofattachment arms 64. -
Attachment members 76 may be one of several structures and/or techniques contemplated to attachexample frame 46 toexample implant 12. As shown inFigure 5B ,attachment member 76 may be positioned, looped, wound and/or threaded through one ormore attachment apertures 70 such that themember 76 is prevented from being pulled away from thedistal portion 68 ofattachment arm 64. In other words, windingattachment member 76 through one ormore attachment apertures 70 may effectively affixattachment member 76 onto theattachment arm 64. In other words, it is contemplated thatattachment member 76 may be affixed to thedistal portion 68 of attachment arms 64 (viaattachment apertures 70, for example) without having either end of theattachment member 76 directly attached (e.g., welded, tied, etc.) to any structure (e.g., frame 46). In some instances,member 76 may be wrapped and/or looped throughattachment apertures 70 one or more times to provide a friction fit and/or resistive tension to unraveling or unwinding as a withdrawal force is applied toattachment member 76. - While
Figure 5B shows asingle attachment member 76 extending between twoattachment apertures 70, it is contemplated thatattachment member 76 may extend and/or wrap between two ormore attachment apertures 70. For example, it is contemplated thatattachment member 76 may be woven (e.g., over-and-under) through threeapertures 70 in order to lockmember 76 to thedistal end 68 ofattachment arm 64. - The above discussion and the forgoing examples are not intended to limit the disclosure to using an attachment member (e.g., wire, thread, cable, etc.) to attach
frame 46 to implant 12. Rather, a variety of methodologies may be utilized to attachframe 46 to implant 12. For example, adhesives may be used alone or in combination with another attachment mechanism to attachframe 46 to implant 12. Additionally, a variety of injection molding techniques may be employed to attachframe 46 to implant 12. Further, combinations of the disclosed techniques may be used to attachframe 46 to implant 12. For example, anattachment member 76 may be used in conjunction with an adhesive to attachframe 46 to implant 12 without having to windattachment member 76 throughattachment apertures 70. - As stated above, it is contemplated in the examples discussed herein that
frame 46 may be able to be "detached" fromimplant 12. For example,frame 46 may be configured to detach fromimplant 12 afterimplant 12 has been affixed to a target site in the body, such as with staples and/or sutures. Therefore, it can be appreciated that in some examples disclosed herein,frame member 46 may be temporarily attached to implant 12. For example,frame member 46 may be coupled, affixed or attached to implant 12 while positioned withindelivery sheath 42, deployed out ofdelivery sheath 42 and maneuvered into position relative to a target site. Once positioned at the target site (e.g., along the tendon and/or humeral head),implant 12 may be rigidly affixed to the target site, such as stapled and/or sutured to bone and/or tendon tissue at the target site. However, onceimplant 12 has been rigidly affixed to the target site,frame 46 may be pulled away (e.g., detached) fromimplant 12 and removed from the body. -
Figure 5B shows an example attachment configuration which may allowframe 46 to detach fromimplant 12.Figure 5B showsattachment member 76 wound in aspiral pattern 80 along the surface ofimplant 12 facing a target site. In other words,attachment member 76 may form aspiral pattern 80 that remains in a plane substantially parallel to the plane of the surface ofimplant 12 which faces a target site. Further, it can be appreciated thatattachment member 76 may extend from the side ofattachment arm 64 facing away fromimplant 12, through the combined thickness of theattachment arm 64 andimplant 12, eventually exitingimplant 12 on the surface ofimplant 12 facing a target site. Further, it can be appreciated that thespiral pattern 80 shown inFigure 5B is one of a variety of configurations for whichattachment member 76 may be wound in order to preventframe 46 from prematurely releasing fromimplant 12. -
Attachment member 76 may have a first end secured to a free distal end ofattachment arm 64 positioned on a first side ofimplant 12 and have a second end positioned on a second, opposite side ofimplant 12. In some instances,attachment member 76 may extend throughimplant 12 from the first side ofimplant 12 to the second side ofimplant 12. However, in other instances,attachment member 76 may extend around an edge ofimplant 12 from the first side ofimplant 12 to the second side ofimplant 12. - The
attachment member 76 may be configured to be detached fromimplant 12 upon application of a threshold level of force. For example, thespiral pattern 80 shown inFigure 5B may provideframe 46 the ability to detach fromimplant 12 when a force greater than or equal to a threshold "pull-away force" is applied toframe 46. For example, afterimplant 12 is affixed to a target site, a clinician may apply a force to frame 46 (via a tether, for example) such thatframe 46 is pulled away fromimplant 12. Provided the force is great enough (e.g., the threshold force is met), attachment members 76 (e.g.,spiral portion 80 ofattachment member 76 shown inFigures 5B ) may be unwound and pulled back through the "body" (e.g., thickness) ofimplant 12, thereby releasingframe 46 fromimplant 12. In other words, provided a threshold pull-away force is applied to frame 46, theattachment member 76 forming the spiral 80 shown inFigure 5B may unwind and pull back throughimplant 12. In some examples, the threshold "pull-away" force for theframe 46 to release fromimplant 12 may be about 0.25 lb to 1.75 lb, or may be about 0.75 lb to about 1.25 lb, or may be about 1.0 lb. Accordingly, the threshold "pull-away" force to release each of the fourattachment member 76 fromimplant 12 may be about 0.0625 lb to 0.4375 lb, or may be about 0.1875 lb to about 0.3125 lb, or may be about 0.25 lb. -
Figure 5C shows another example method to attachframe 46 to anexample implant 12. As shown inFigure 5C ,attachment member 76 may include a spiral 81 positioned on the surface of theimplant 12 which faces away from a target site (similar to spiral 80 shown inFigure 5B ). Additionally,Figure 5C shows thatattachment member 76 may include asecond spiral 82 positioned on the surface ofattachment arm 68 that faces away fromimplant 12. In other words,Figure 5C shows twospirals 81/82 formed at opposite ends ofattachment member 76 and positioned on both theattachment arm 64 facing away from implant 12 (e.g., spiral 82 ofFigure 5C ) and on the side of theimplant 12 lying along a treatment site (e.g., spiral 81 ofFigure 5C ). The configuration ofspirals 81/82 may provide aframe 46 with a "releasable" connection to implant 12 similar to that discussed with respect toFigure 5B . -
Figure 6 showsexample frame 46 coupled toexample implant 12 viaattachment members 76 as described above. Further,Figure 6 showsframe 46 in combination withimplant 12 coupled to exampleimplant delivery system 40. Similar to that discussed with respect toFigure 2 ,implant delivery system 40 includesimplant delivery shaft 44 extending through anexample lumen 84 of anexample delivery sheath 42. - Further,
Figure 6 shows thedelivery shaft 44 coupled to frame 46 via aconnection assembly 88.Connection assembly 88 may include afirst connection member 90 attached to thehead portion 58 offrame 46 and asecond connection member 92 attached to thedistal end 50 ofdelivery shaft 44. WhileFigure 6 does not directly showfirst connection member 90 attached directly tosecond connection member 92, it can be appreciated that the first andsecond connection members 90/92 ofconnection assembly 88 may form a mating connection. For example, in some instances,first connection member 90 may form a male connection member whilesecond connection member 92 may form a mating female connection member. In other words, in some examplessecond connection member 92 may include a cavity which is configured to extend over and allowfirst connection member 90 to be inserted therein. In other instances, thefirst connection member 90 may be a female connection member, whilesecond connection member 92 may be a mating male connection member. - Additionally, as shown in
Figure 6 , it is contemplated thatsecond connection member 92 may disengage or decouple fromfirst connection member 90. For example, in some instances connection assembly 88 (including first andsecond connection members 90/92) may be defined as a "quick release" connection assembly, or otherwise decoupling connection assembly. It is further contemplated that a variety of design configurations may be employed to engage/disengage (i.e., couple/decouple) the first andsecond connection members 90/92 from one another. For example, first andsecond connection members 90/92 may be coupled via a threaded connection, friction fit, spring loaded connection, bayonet connection, movable collar or other actuation mechanism, or the like. Further,connection member 90/92 may be engaged/disengaged by an operator of the device. - In some instances,
delivery shaft 44 may be attached (viaconnection assembly 88, for example) to thehead portion 58 offrame member 46. As shown inFigure 6 , thefirst connection member 90 ofconnection assembly 88 may attach to headportion 58 via an aperture 60 (shown inFigure 3 ). In some instances,first connection member 90 may be attached to thehead portion 58 offrame member 46 via a variety of mechanical fastening means (e.g., injection molding, encapsulation, bonding, etc.). - Additionally, in some instances,
delivery system 40 may include atether 96 coupled toframe 46. For example,Figure 6 , as well asFigure 16 , showstether 96 attached tofirst connection member 90. However, it is contemplated that in someexamples tether 96 may be coupled directly or indirectly to frame 46 and/or any other suitable structure. Further,tether 96 may be a rigid structure (e.g., rod) or it may be a non-rigid structure (e.g., a wire, cable, etc.). Additionally, it can be appreciated thattether 96 may be long enough to extend fromframe 46 positioned at the target site to a location exterior of the patient through insertion site (i.e., incision), such as through alumen 86 ofdelivery shaft 44 and out of a proximal portion of the implant delivery system 40 (e.g., proximal portion of delivery shaft 44). However, it is also contemplated that in someexamples tether 96 may extend fromframe 46 outside ofdelivery shaft 44 and out of a proximal portion of theimplant delivery system 40. As will be discussed in greater detail below, thetether 96 may be utilized to withdraw theframe 46 out of the body after theimplant 12 has been attached. - As discussed above, in some instances, a physician may insert implant delivery system 40 (including a
delivery sheath 42,delivery shaft 44,frame 46 and implant 12) through an incision and position the distal end of theimplant delivery system 40 adjacent a target implant site (e.g., torn tendon). Once adjacent the target site, the physician may manipulate theimplant delivery shaft 44 to advance the implant (while attached to the detachable frame 46) out of thedelivery sheath 42 adjacent the target implant site. For example, the physician may retractdelivery sheath 42 proximally relative todelivery shaft 44 andframe 46 and/or may advancedelivery shaft 44 andframe 46 distally relative todelivery sheath 42. -
Figure 6 showsframe 46 andimplant 12 deployed from thedistal portion 48 ofdelivery sheath 42. In some instances,frame 46 andimplant 12 may have a substantially concave shape with respect todelivery sheath 42. It can be appreciated that the concave shape offrame member 46 andimplant 12 may facilitate positioning theimplant 12 along the generally rounded shape of the human shoulder. - However, when positioned in the delivery sheath 42 (e.g., prior to deployment) the
frame 46 andimplant 12 may be wrapped around thedelivery shaft 44 in a convex configuration. Therefore,frame 46 andimplant 12 may shift from a first convex configuration (while wrapped tightly arounddelivery shaft 44 withinlumen 84 of delivery sheath 42) to a second concave configuration when advanced (e.g., deployed) out ofsheath 42. - In other words,
frame 46 andimplant 12 may be attached to thedelivery shaft 44 via theconnection assembly 88 when positioned within thelumen 84 of thedelivery sheath 42. In one example, when positioned within thedelivery sheath 42, theframe 46 andimplant 12 may wrap, or extend around, thedelivery shaft 44. The position of theframe 46 andimplant 12 may be in a convex configuration with respect to thedistal end 50 of thedelivery shaft 44. As theframe 46 andimplant 12 are deployed out of thedistal end 50 of thedelivery shaft 44, theframe 46 andimplant 12 may "shift" from a convex configuration to a concave configuration (as viewed with respect to thedistal end 50 of delivery shaft 44). -
Figure 7 illustrates another exampledetachable frame member 146 attached to animplant 112. It is contemplated that any of the frame members and/or implants disclosed herein may be utilized in conjunction with any of the delivery systems and/or delivery system features disclosed herein. Further,frame member 146 and/orimplant 112 may be similar in form and functionality to other example frame members described herein. For example,detachable frame member 146 andimplant 112 may have aproximal portion 152 which, for purposes of discussion herein, may be adjacent delivery shaft 44 (described above) and be configured to be positioned adjacent humerus 16 (shown inFigure 1 ). Further,detachable frame member 146 andimplant 112 may have adistal portion 154 which, for purposes of discussion herein, may extend away from deliver shaft 44 (described above) and be configured to be positioned adjacent tendon 24 (shown inFigure 1 ). -
Figure 8 shows exampledetachable frame member 146. As illustrated inFigure 8 ,frame member 146 may include acentral body portion 156. In some examples,body portion 156 may be understood to define a circular, ovular, square, rectangular or similar shaped framework from which other members may extend. For example,body portion 156 offrame 146 may bear some resemblance to an elongated rectangle having aproximal portion 152 and adistal portion 154.Body portion 156 may include one ormore apertures 174. Further,frame 146 may include ahead portion 158 positioned within and/or extending away from thebody portion 156.Head portion 158 may include anaperture 160. - As shown in
Figure 8 ,detachable frame 146 may include one ormore attachment arms 164 extending away frombody portion 156. Eachrespective attachment arm 164 may include aproximal portion 166 and adistal portion 168. Theproximal portion 166 of each of theattachment arms 164 may be rigidly attached tobody portion 156, while thedistal portion 168 may be a free end of theattachment arm 164 spaced away frombody portion 156. In some examples (such as that shown inFigure 8 ),attachment arms 164 andhead portion 158 may form a monolithic structure withbody portion 156. In other words, in someexamples body portion 156,head portion 158 andattachment arms 164 may be formed (e.g., machined, cut, shaped, stamped, laser-cut, etc.) as a unitary structure from a single piece of material. However, the above discussion is not intended to be limiting. Rather, it is contemplated thatdetachable frame 146 may be constructed using alternative materials and/or manufacturing methodologies. For example,frame 146, or portions thereof, may be constructed from a polymeric material, a ceramic material and/or other various materials. Additionally,frame 146 may be manufactured via an injection molding or alternative polymer manufacturing methodologies. Alternatively,frame 146 may be formed through a 3-D printing process, if desired. Further, different portions of frame 146 (as described above, for example), may be made from a variety of materials and combined using alternative methodologies. For example,attachment arms 164 may be made from a polymer material and combined with a central frame member constructed from a metal. Variations of combining different materials with different portions offrame 146 are contemplated. -
Figure 8 further illustrates thatattachment arms 164 may include a variety of shapes. For example, in some instances,attachment arms 164 may include a bow and/or general curvilinear shape (such as that shown in theattachment arm 164 closest to head portion 158). In other examples, anattachment arm 164 may include additional features, such as thecircular portion 172 positioned adjacent one or more attachment arms 164 (as shown adjacent twoattachment arms 164 located farthest from head portion 158). Similar to that discussed above with respect tocircular portion 72 shown inFigure 4A , thecircular portion 172 may be designed to provide a "visual engagement marker" for which a user (e.g., clinician) may be able to engage a secondary medical device and manipulate the position of theframe 146 after initial deployment. In other words, a clinician may be able to engage a secondary medical device withcircular portion 172 and thereafter manipulate the secondary medical device to alter the initial deployment position offrame 146. - In some examples,
frame 146 may include a variety of shapes and/or geometric arrangements. For example, while the above discussion has focused on the shape offrame 146 shown inFigure 8 , it is not intended to be limiting. For example,frame 146 may include one ormore stiffening members 162 extending throughoutframe 146, such as throughoutbody portion 156. Further, stiffeningmember 162 may be arranged within frame 146 (e.g., within body portion 156) such that it creates the one ormore apertures 174. The number, shape, configuration and/or arrangement of stiffeningmembers 162 and/orapertures 174 may depend on the particular performance characteristics desired to be imparted todetachable frame 146. For example,additional stiffening members 162 may be added toframe 146 to provide increased stiffness to frame 146. In other instances, stiffeningmembers 162 may take on particular geometries that increase stiffness or flexibility in a particular direction and/or region while decreasing stiffness or flexibility in a different direction and/or region, for example. - Stiffening
members 162 may be located (e.g., arranged) throughoutframe 146 in a variety of configurations to provide additional stiffness and/or structural integrity to a particular frame shape. In other words, a wide variety of different shapes and/or arrangements of stiffeningmembers 162 may be included withinframe 146 to impart customized performance characteristics onframe 146. For example, in some instances it may be desirable to transfer rotational forces placed onhead portion 158 toattachment arms 164 positioned at thedistal portion 154 offrame 146. The addition of stiffeningmembers 162 may transfer those rotational forces throughout frame 146 (e.g., to thedistal portion 154 of frame 146) while minimizing the amount of force lost and/or dissipated throughout theframe 146 due to undesirable flexing of the frame members. -
Figure 8 further illustrates thatframe 146 may include anextension member 180 extending away from head portion 158 ("when viewed in the planar configuration shown inFigure 8 ).Extension member 180 may include aconnection aperture 182 formed in aproximal region 184 ofextension member 180. Additionally,extension member 180 may include one ormore extension arms 186 extending to a proximal portion ofbody portion 156.Extension arms 186 may be part of (e.g., a monolithic structure with)body portion 156.Figure 8 illustrates thatextension arms 186 may include a curve. However, it is contemplated that the shape of extension portion 180 (includingextension arms 186 and/or aperture 186) may include a variety of shapes and/or configurations. -
Figure 8 further illustrates thatframe 146 may include one ormore attachment channels 170 located along adistal portion 168 of one ormore attachment arms 164. For example,Figure 8 showsattachment channels 170 positioned at adistal portion 168 of theattachment arms 164. As will be discussed in greater detail below,attachment channels 170 may be utilized to attach theframe 146 to an example implant. WhileFigure 8 shows asingle attachment channel 170 positioned along adistal portion 168 of each of theattachment arms 164, the illustrated number ofattachment channels 170 is not intended to be limiting. In other words, it is contemplated that one ormore attachment channels 170 may be positioned along any portion offrame 146. The number ofattachment channels 170 positioned alongframe 146 may be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20 or more. In other instances,attachment arms 164 may be devoid ofattachment channels 170. In such instances,attachment arms 164 may include an alternative attachment structure for attaching to an implant. - When combined with an example implant,
frame 146 may be defined as having a first surface that faces away from the implant when the implant is attached to frame 146 (e.g., a first surface that faces away from a target site in the body) and a second surface that faces the example implant (e.g., a second surface that faces a target site in the body). In some instances,attachment channels 170 may extend from the first surface to the second surface. In other words, in some instances,attachment channels 170 may be defined as openings that extend through the thickness offrame 146 from the first surface of theframe 146 that faces away from the implant to the second surface of theframe 146 that faces toward the implant. - As stated above,
attachment channels 170 may be utilized to attach and/orcouple frame 146 to an example implant.Figure 9A shows anexample frame 146 attached to anexample implant 112. Further,Figure 9A showsexample frame 146 attached toexample implant 112 at the distal or free end of each of the fourattachment arms 164, respectively. Attachment of free distal ends ofattachment arms 164 to implant 112 may be made by any desired attachment mechanism. - As will be described in greater detail below,
Figure 9A further illustrates locking covers 198 positioned along thedistal portion 168 ofattachment arms 164. Lockingcover 190 may be used in conjunction withattachment channels 170 to secureframe 146 toimplant 112. Locking covers 198 may be constructed of a variety of materials. For example, locking covers 198 may include a metal, a polymer or combinations thereof, for example. -
Figure 9B shows a detailed view of a portion offrame 146 attached to animplant 112 in a configuration similar to that discussed above with respect toFigures 7 and8 . Specifically,Figure 9B showsexample attachment arm 164 including adistal portion 168.Attachment channels 170 are positioned along thedistal portion 168 of theattachment arm 164. Additionally,Figure 9B shows an example attachment member (e.g. wire) 176 extending between and/or through one or more of theattachment channels 170 located on thedistal portion 168 ofattachment arms 164. -
Attachment member 176 may include a variety of structures and/or techniques designed to attachexample frame 146 toexample implant 112. As shown inFigure 9B ,attachment member 176 may be inserted, looped, wound and/or threaded through one ormore attachment channels 170 such that theattachment member 176 is prevented from being pulled away from thedistal portion 168 ofattachment arm 164. In other words, sliding, inserting and/or windingattachment member 176 through one ormore attachment channels 170 may effectively affixattachment member 176 toattachment arm 164. In other words, it is contemplated thatattachment member 176 may be affixed to thedistal portion 168 of attachment arms 164 (viaattachment channels 170, for example) without having either end of theattachment member 176 permanently attached (e.g., welded, etc.) to any structure (e.g., frame 146). In some instances,attachment member 176 may be wrapped and/or looped throughattachment channel 170 one or more times to provide a friction fit, interference fit, and/or resistive tension to unraveling or unwinding as a withdrawal force is applied toattachment member 176. -
Figure 9B further illustrates thatattachment channel 170 may include an opening that extends through the thickness of attachment arm 164 (e.g., from a top surface to the bottom surface of attachment arm 164) and also thatattachment channel 170 may extend through thesidewall 171 ofattachment arm 164 such thatattachment member 176 may be laterally inserted into and/or removed fromattachment channel 170. Additionally,attachment channel 170 may include one or more widths along the length ofattachment channel 170. For example,Figure 9B showsattachment channel 170 including a first width "X" which extends throughsidewall 171 ofattachment arm 164.Attachment channel 170 further includes a second width "Y." In some instances, width "X" may be narrower than width "Y." Further, it can be appreciated that width "X" may be sized such that it is slightly smaller than the width (e.g., diameter) ofattachment member 176. Additionally, the general shape ofattachment channel 170 may be designed such that it may flex to an extent sufficient to permit attachment member to extend (e.g., be inserted) through the narrower portion ofchannel 170 defined by the width "X" and further advanced into the wider portion ofchannel 170 defined by width "Y." -
Figure 9B further illustratesexample detents 173. Detents may extend inwardly from the surface ofsidewall 171. In some instances,detents 173 may be designed to mate with a protrusion or tab extending from an inner surface of lockingmember 198. Alternatively, detents may be protrusions or protuberances extending from the surface ofattachment arm 164 configured to engage and/or mate with a feature of lockingcover 198. - Similar to that described above with respect to
Figure 5B ,Figure 9B shows an example attachment configuration which may allowframe 146 to detach fromimplant 112. For example,Figure 9B shows a portion ofattachment member 176 wound in aspiral pattern 180 along the surface ofimplant 112 facing a target site. In other words,attachment member 176 may form aspiral pattern 180 that remains in a plane substantially parallel to the plane of the surface ofimplant 112 which faces a target site. Further, it can be appreciated thatattachment member 176 may extend from the side ofattachment arm 164 facing away fromimplant 112, through the combined thickness of the attachment arm 164 (e.g., via attachment channel 170) andimplant 112, eventually exitingimplant 112 on the surface ofimplant 112 facing a target site. Theattachment member 176 may include a retention portion, such as aspiral pattern 180 positioned on the opposite side ofimplant 112 fromattachment arm 164 forcoupling implant 112 toattachment arm 164. Further, it can be appreciated that thespiral pattern 180 shown inFigure 9B is one of a variety of configurations for whichattachment member 176 may be wound in order to preventframe 146 from prematurely releasing fromimplant 112. Further, as described above, when a sufficient threshold pull-away force is applied to frame 146, the portion ofattachment member 176 forming the spiral 180 shown inFigure 9B may unwind and/or straighten and pull back throughimplant 112. Instead ofspiral 180, it is contemplated thatattachment member 176 may have another shaped configuration positioned on the surface ofimplant 112 facing a target site, which may be straightened or release upon a sufficient removal force to pull back throughimplant 112. -
Figure 9B further shows lockingmember 198 positioned along thedistal portion 168 ofattachment arm 164. In at least some examples disclosed herein, lockingmember 198 may be able to translate (e.g., slide) alongattachment arm 164. For example,Figure 9B shows thedistal portion 168 ofattachment arm 164 extending through at least a portion of lockingmember 198. In such instances, lockingmember 198 may be a sleeve in whichattachment arm 164 extends through lumen of sleeve. In at least some examples disclosed herein, lockingmember 198 is designed such that there is sufficient clearance between the inner surface (e.g., the inner diameter) of lockingmember 198 and the outer surface (e.g., the outer diameter) ofattachment arm 164 such that lockingmember 198 can slide alongattachment arm 164. - It can further be appreciated that locking
member 198 may slide alongattachment arm 164 to a position in which lockingmember 198 coversattachment member 176 and/orattachment channel 170. For example,Figure 9C shows lockingmember 198 positioned at thedistal end 168 of theattachment arm 164. Further,Figure 9C shows lockingmember 198 positioned over the top (e.g., covering) ofattachment member 176 andattachment channel 170. It can be appreciated that when positioned over the top of theattachment member 176 and/orattachment channel 170, lockingmember 198 may pinch, hold, secure, and/orlock attachment member 176 toattachment arm 164, such as by securing or lockingattachment member 176 inattachment channel 170. In some examples, lockingmember 198 may resemble a "compression-like" fitting wherein lockingmember 198 is drawn over the top ofattachment member 176, thereby compressingattachment member 176 ontoattachment arm 164 such thatattachment member 176 is prevented from separating fromattachment arm 164. - Additionally, when locking
member 198 is positioned over the top ofattachment member 176 and/orattachment channel 170, lockingmember 198 may lock in place viadetents 173. In other words, when lockingmember 198 is positioned in its securement position, in which theattachment member 176 is secured toattachment arm 164, a feature of lockingmember 198 engagesdetents 173 to inhibit or prevent lockingmember 198 from moving back to the unsecured position shown inFigure 9B . For example, it can be appreciated that the lockingmember 198 may include one or more inwardly projecting tabs (not shown) designed to be inserted (e.g., mate with)detents 173. The combination of tabs anddetents 173 are, therefore, designed to prevent lockingmember 198 from moving alongattachment arm 164 after having been positioned over top theattachment member 176 and/orattachment channel 170. - During assembly of
implant 112 to frame 146,attachment member 176 may be passed throughimplant 112 with distal enlarged portion (e.g., spiral 180) positioned on a second surface ofimplant 112 facing away fromframe 146. Portion ofattachment member 176 extending from a first surface ofimplant 112 facingframe 146 may then be passed throughattachment channel 170, such as passed laterally intoattachment channel 170 and then bent, wound or otherwise manipulated aroundattachment arm 164. Lockingmember 198 may then be moved from a first, unsecured position, shown inFigure 9B to a second, secured position, shown inFigure 9C to secureattachment member 176 toattachment arm 164. - The above discussion describes example configurations of the distal end portions of the attachment arms and provides example configurations of how the attachment arms may be connected to an example implant. However, these configurations are not intended to be limiting. Rather, a variety of attachment arm configurations are contemplated. For example,
Figure 9D shows a detailed view of a portion of anotherexample frame 246 attached to implant 112 in a configuration similar to that discussed above with respect toFigures 9A-9C . - Specifically,
Figure 9D showsexample attachment arm 264 including adistal portion 268. Anattachment channel 270 is positioned along thedistal portion 268 of theattachment arm 264. Additionally,Figure 9D shows an example attachment member (e.g. wire) 276 extending through theattachment channel 270 located on thedistal portion 268 ofattachment arm 264.Figure 9D further illustrates that thedistal portion 268 of theattachment arm 264 may include one ormore openings 273 that extend through the thickness of attachment arm 264 (e.g., from a top surface to the bottom surface of attachment arm 264) and also thatattachment channel 270 may extend through thesidewall 271 ofattachment arm 264 such thatattachment member 276 may be laterally inserted into and/or removed fromattachment channel 270. As illustrated inFigure 9D ,attachment member 276 may be looped through one ormore openings 273 and implant 112 (the dashed line inFigure 9D depicts theattachment member 276 being looped through implant 112) in addition to being secured withinattachment channel 270. -
Attachment member 276 may include a variety of structures and/or techniques designed to attachexample frame 246 toexample implant 112. As shown inFigure 9D ,attachment member 276 may be inserted, looped, wound and/or threaded through one ormore attachment channels 270 and/oropenings 273 such that theattachment member 276 is prevented from being pulled away from thedistal portion 268 ofattachment arm 264. In other words, sliding, inserting and/or windingattachment member 276 through one ormore attachment channels 270 and/oropenings 273 may effectively affixattachment member 276 toattachment arm 264. In other words, it is contemplated thatattachment member 276 may be affixed to thedistal portion 268 of attachment arms 264 (viaattachment channels 270 and/oropenings 273, for example) without having either end of theattachment member 276 permanently attached (e.g., welded, etc.) to any structure (e.g., frame 246). In some instances,attachment member 276 may be wrapped and/or looped throughattachment channel 270 and/oropenings 273 one or more times to provide a friction fit, interference fit, and/or resistive tension to unraveling or unwinding as a withdrawal force is applied toattachment member 276. - Further,
Figure 9E illustrates that in some examples, a lockingmember 298 may be molded directly onto and/or otherwise positioned on thedistal portion 268 ofattachment arm 264. For example,Figure 9E shows anexample locking member 298 positioned along thedistal portion 268 of theattachment arm 264 whereby the lockingmember 298 covers at least a portion of theattachment member 276 and/orattachment channel 270. Further,Figure 9E shows lockingmember 298 encircling (e.g., covering)attachment member 276 andattachment channel 270. It can be appreciated that when molded overattachment member 276 and/orattachment channel 270, the lockingmember 298 may pinch, hold, secure, and/orlock attachment member 276 toattachment arm 264, such as by securing or lockingattachment member 276 inattachment channel 270 and/oropenings 273. In some examples, lockingmember 298 may compressattachment member 276 ontoattachment arm 264 such thatattachment member 276 is prevented from separating fromattachment arm 264. It is contemplated that any of the examples described herein may utilize a sliding locking member 198 (as shown and described inFigures 9A-9C ) and/or an over-molded locking member 298 (as shown and described inFigure 9E ). -
Figure 10 illustrates a perspective view offrame 146 representing theconfiguration frame 146 would be in when inserted into the body. For example,Figure 10 showsframe 146 includingextension member 180 coupled to both connection member 90 (similar in form and function toconnection member 90 discussed above) andhead portion 158. As discussed above,Figure 10 illustrates that a tether 96 (similar in form and function to tether 96 discussed above) may be coupled toconnection member 90 and extend proximally therefrom. Further, as illustrated inFigure 10 ,extension member 180 may curve upward and back on itself (e.g., upward and back toward thedistal end 154 of frame 146). Further,head portion 158 may extend upward and away from thebody portion 156 offrame 146. It can be appreciated thatconnection member 90 may coupleextension member 180 tohead portion 158 via theapertures connection member 90 may be inserted through bothapertures extension member 180 tohead portion 158. Additionally,Figure 10 shows atack member 94 extending through a portion offrame 146.Tack member 94 will be described in greater detail below. - Additionally,
Figure 10 illustrates thatframe 146 may form a concave configuration when being inserted into the body. It can be appreciated that the concave shape offrame 146 may follow the contour of anatomy (e.g., shoulder) in which the example implant is to be secured. -
Figure 11 illustrates a side view offrame 146 described inFigure 10 .Figure 11 illustrates the concave shape offrame 146. Additionally,Figure 11 showsextension member 180 curving upward and back towarddistal portion 154 offrame 146 as described above. Further,Figure 11 showshead portion 158 extending upward and away frombody portion 156 offrame 146.Extension member 180 and thehead portion 158 are coupled to one another viaconnection member 90 extending throughconnection apertures 182, 1 60. Thus,connection apertures connection member 90 extending therethrough. Additionally,Figure 11 showstack member 94 extending through a portion offrame 146, such that the distal tip oftack member 94 penetrates throughimplant 112 to be positioned a distance below the lower surface (the surface ofimplant 112 opposite the frame 146) ofimplant 112.Figure 11 further illustrates thetether member 96 described above with respect toFigure 10 . In some examples, thetether member 96 may be coupled to thetack member 94. While the above discussion describes thetether member 96 indirectly coupled toframe member 146 via theconnection member 90, it is contemplated that in other instances thetether member 96 may be directly coupled to frame 146 (or other similar frame members described herein). - In some instances, the configuration of
frame 146 shown inFigures 7-11 may provide both precise control and maneuverability to a clinician or other operator of the medical device. For example, the geometry of theextension member 180 in combination withhead portion 158 andconnection member 90 may provide precise maneuverability of thedistal portion 154 offrame 146. For example, in some instances, an operator may manipulateconnection member 90 with a delivery shaft 44 (described above). The delivery shaft may be able to impart a downward force (e.g., a force directed toward a patient's shoulder) ontoframe 146 via the combination ofconnection member 190,extension member 180 andhead portion 158. Further, the concave geometry offrame 146 may allow the distal portion offrame 146 to extend along the surface of the shoulder for which theimplant 112 is to be positioned. In other words, the geometry offrame 146 shown inFigure 10 andFigure 11 may prevent thedistal portion 154 of frame 146 (including attachment arms 164) from pulling up and away from the shoulder surface as a clinician manipulatesframe 146 within the body. Further, the geometry offrame 146 shown inFigures 10 and11 may allow thedistal portion 154 offrame 146 to be advanced toward the surface of the shoulder in which animplant 112 is to be positioned. - Additionally, the geometry of
frame 146 shown inFigure 11 may allow a clinician improved visibility of the frame 146 (e.g., thedistal portion 154 of frame 146) during implantation of the medical device. For example, in some instances a clinician may position a camera adjacent the implantation site. The clinician may utilize the camera to accurately maneuver and/or position an example implant into the patient. However, in some instances, the camera my obscure and/or impede the visibility of all or a portion of the frame or implant (e.g.,frame 146 and/or implant 112). However, the geometry offrame 146 shown inFigure 11 may allow the connection member 90 (anddelivery sheath 44 coupled to connection member 90) to be inserted at an angle (depicted as "θ" inFigure 11 ) which is directed away from thedistal end 154 offrame 146. It can be appreciated that angle θ may be measured from aline 155 that is orthogonal to aline 151 tangent to apoint 153 generally positioned at the apex of a curve defined bybody portion 156. Orientingconnection member 90 such that it is directed away from thedistal end 154 offrame 146 may increase the amount of space for which a camera may be placed during a procedure. In other words, a clinician may be able to maneuver the camera such that it provides improved visibility of all or a portion of the medical device being implanted (e.g.,implant 112 via frame 146). - As briefly described above with respect to
Figures 10 and11 , any of the implant delivery systems described herein may include a tack member designed to "anchor" the delivery system in place prior to aclinician affixing implant 12 to the bone and/or tendon. For example,Figure 12A illustrates atack member 94 extending distally from thefirst connection member 90. As shown inFigure 12A ,tack member 94 may extend distally fromfirst connection member 90 and be substantially perpendicular to implant 12 and/orframe 46. In some instances,tack member 94 may extend generally parallel to the longitudinal axis ofdelivery sheath 42 and/ordelivery shaft 44 with theframe 46 andimplant 12 extending generally perpendicular to the longitudinal axis ofdelivery sheath 42 and/ordelivery shaft 44. However, this configuration is not intended to be limiting. Rather, it is contemplated thattack member 94 may extend distally from thefirst connection member 90 and/orframe 46 at an oblique angle to the longitudinal axis ofdelivery sheath 42,delivery shaft 44, and/orframe 46. - In some instances,
tack member 94 may resemble a cylindrical pin or rod extending away fromframe 46. Thetack member 94 may be designed to be rigid enough to be pounded and/or inserted into bone. For example, in some instances, a clinician may apply a force to a proximal portion of the implant delivery system 40 (e.g., delivery shaft 44) such thattack member 94 may be "hammered" into a body structure (e.g., bone). In some instances,tack member 94 may include a tapered distal tip, which may be a sharpened or blunt tapered distal tip in some instances. - In some instances,
tack member 94 may be stationary (e.g., fixed in place) relative to frame 46 and/orfirst connection member 90 ofconnection assembly 88. For example,tack member 94 may extend distally fromfirst connection member 90 and away from the surface offrame 46 which faces a target site. - While the above discussion describes
example tack member 94, the discussion relative thereto is not intended to be limiting. Rather, a variety of tack member designs and configurations are contemplated herein. Different tack members may be designed to impart specific insertion forces while the tack is being driven into a body structure (e.g., bone). Additionally, these tack designs may also provide specific release forces upon removing the tack from a body structure (e.g., bone). - For example,
Figure 12B illustrates anothertack member 394.Tack member 394 may include aproximal end region 340 and adistal end region 350. Thedistal end region 350 may includeshaft member 352 and atip member 354. Thetip member 354. may be positioned at the distal end of theshaft member 352. Additionally, in some examples thetack member 394 may include one or more radially enlarged portions positioned along theshaft member 352. Radially enlarged portions may be protuberances or lobes (e.g., continuous or discontinuous circumferential and/or helical rims, etc.) extending radially outward beyond the outer surface of theshaft member 352, for example. For example,Figure 12B shows a first radially enlargedportion 356A and a second radially enlargedportion 356B positioned along theshaft member 352. However, it is contemplated that thetack member 394 may include a single radially enlarged portion or more than two radially enlarged portions. For example, thetack member 394 may include 1, 2, 3, 4, 5, 6, 7, 8 or more radially enlarged portions. In some examples, the first radiallyenlarged portion 356A may be positionedadjacent tip member 354. - In some examples the
proximal end region 340 of thetack member 394 may include avertical bore 355 extending inward from aproximal end surface 357 of thetack member 394. Thevertical bore 355 may extend along thelongitudinal axis 359 of thetack member 394. Additionally,Figure 12B illustrates the tether member 96 (discussed with respect toFigure 12A ) extending within thevertical bore 355. As shown inFigure 12B , thevertical bore 355 may include a profile which mirrors the shape of thetether member 96 extending within thevertical bore 355. It can further be appreciated that thetether member 96 may be attached to thetack member 394 via thevertical bore 355. In other words, thetether member 96 may be rigidly fixed to thetack member 394 within thevertical bore 355 via a variety of attachment techniques (e.g., welding, adhesive, crimping, swaging, etc.) The diameter of thetether member 96 is illustrated as being less than the diameter of thevertical bore 355, however, it is noted that upon securement of thetether member 96 withinvertical bore 355, thetether member 96 may substantially occupy thebore 355. -
Figure 12B illustrates that the first radiallyenlarged portion 356A and the second radiallyenlarged portion 356B may be spaced longitudinally away from one another along theshaft member 352 with a portion of theshaft 352 positioned therebetween. For example,Figure 12B shows the distance at which each of the first radiallyenlarged portion 356A and the second radiallyenlarged portion 356B are spaced away from thedistal end 360 of thetip member 354. For example, "X1" depicts the distance at which the first radiallyenlarged portion 356A is spaced away from thedistal end 360 of thetip member 354. In some examples, X1 may be between 0.030 inches and 0.090 inches, or may be between 0.045 inches and 0.075 inches, or may be about 0.059 inches, for example. Additionally, "X2" depicts the distance at which the second radiallyenlarged portion 356B is spaced away from thedistal end 360 of thetip member 354. In some examples, X2 may be between 0.100 inches and 0.150 inches, or may be between 0.115 inches and 0.130 inches, or may be about 0.124 inches. - However, it is further contemplated that in some examples the first radially
enlarged portion 356A and the second radiallyenlarged portion 356B may be adjacent one another. In other words, it is contemplated that the first radiallyenlarged portion 356A and the second radiallyenlarged portion 356B may be positioned directly adjacent one another. It is further contemplated that in some examples thetack member 394 may include more than two radially enlarged portions, some of which may be positioned away from other radially enlarged portions and/or some of which may be positioned directly adjacent other radially enlarged portions. - Additionally, the detailed view of
Figure 12B illustrates that the first radiallyenlarged portion 356A and/or the second radiallyenlarged portion 356B may include acurved portion 357 having an outer surface which extends laterally away from the outer surface of theshaft member 352 located adjacent to thecurved portion 357. In other words, thecurved portion 357 of the radiallyenlarged portion 356 may have an outer diameter which is greater than the outer diameter of theshaft member 352 directly adjacent thecurved portion 357. For example, the detailed view ofFigure 12B depicts the distance that curvedportion 357 extends radially outward from the surface of theshaft member 352 as "X3." In some examples, X3 may be between 0.001 inches and 0.015 inches, or may be between 0.005 inches and 0.010 inches, or may be about 0.006 inches. In some examples, the distance that a first radially enlarged portion and a second radially enlarged portion extends away from the surface of theshaft member 352 may be different. For example, a more proximal radially enlarged portion may extend radially outward from the shaft member 352 a greater distance or a lesser distance than a more distal radially enlarged portion. In other examples (like those described above), the distance that a first radially enlarged portion and a second radially enlarged portion extends away from the surface of theshaft member 352 may be substantially equivalent. - It can be appreciated that the distance that curved
portion 357 extends radially away from the surface of theshaft member 352 may correspond to the force required to retract thetack member 394 from a body structure into which thetack 394 may be inserted. It can further be appreciated that the shape, geometry, materials, etc. of thetack member 394 may be tailored to impart specific withdrawal forces from a body structure into which thetack member 394 may be inserted. - Additionally, in some instances, the
shaft member 352 may include a taper. For example, theshaft member 352 may be tapered at an angle relative to thelongitudinal axis 359 of theshaft member 352. In some examples, angle of taper may be about 1 degree to about 5 degrees, for example. -
Figure 12C illustrates another example tack member 494. The tack member 494 may be similar in form and function to other tack members described herein. For example, tack member 494 may include aproximal end region 440 and adistal end region 450. Thedistal end region 450 may includeshaft member 452 and atip member 454. Thetip member 454 may be positioned at the distal end of theshaft member 452. The tack member 494 may further include thevertical bore 455.Figure 12C illustrates thetether member 96 extending within thevertical bore 455. Thetether member 96 may be attached to the tack member 494 via thevertical bore 455 as described above. - Additionally,
Figure 12C illustrates thatshaft member 452 may include one or more radiallyenlarged portions 462 positioned helically along theshaft member 452. Similarly to the radially enlargedportions 356A/356B described above with respect toFigure 12B , the helical radiallyenlarged portion 462 may include a curved portion having an outer surface which extends radially outward beyond the outer surface of theshaft member 452. As illustrated inFigure 12C , the helical radiallyenlarged portion 462 may extend longitudinally along theshaft member 452 in a helical fashion. Additionally, whileFigure 12C shows a single helical radially enlarged portion extending along the surface of theshaft member 452, it is contemplated that the tack member 494 may include more than one helical radiallyenlarged portion 462. For example, tack member 494 may include two helical radially enlarged portions helically arranged along theshaft member 452. In some examples, first and second helical radially enlarged portions may extend aroundshaft member 452 in the same helical direction (e.g., a clockwise direction or a counterclockwise direction) alongshaft member 452. In some examples, first and second helical radially enlarged portions may extend aroundshaft member 452 in opposite directions (e.g., a first helical radially enlarged portion extending in a clockwise direction and a second helical radially enlarged portion may extend in a counterclockwise direction) alongshaft member 452. -
Figure 12D illustrates anotherexample tack member 594. Thetack member 594 may be similar in form and function to other tack members described herein. For example,tack member 594 may include aproximal end region 540 and adistal end region 550. Thedistal end region 550 may includeshaft member 552 and atip member 554. Thetip member 554 may be positioned at the distal end of theshaft member 552. Thetack member 594 may further include thevertical bore 555.Figure 12D illustrates thetether member 96 extending within thevertical bore 555. Thetether member 96 may be attached to thetack member 594 via thevertical bore 555 as described above. - Additionally,
Figure 12D illustrates thattack member 594 may be formed as a composite structure including multiple components formed of dissimilar materials. For example,tack member 594 may includeshaft member 552 along with one ormore fixation members 564 disposed along the shaft member 552 (depicted by the dashed line inFigure 12D ). As shown inFigure 12D , thefixation members 564 may be constructed from materials different from the material used to construct theshaft member 552. For example, thefixation members 564 may be formed from a material which is softer and/or more flexible than the material used to construct theshaft member 552, thus permitting thefixation members 564 to be radially compressible toward the longitudinal axis of thetack member 594. Thefixation members 564 may include a polymeric material, composite material, or any other material with desirable compression/expansion characteristics, while theshaft member 552 may be formed of a metallic material, for example. - As illustrated in
Figure 12D , the one ormore fixation members 564 may surround or otherwise extend radially outward from the surface of theshaft member 552 with theshaft member 552 extending through the one ormore fixation members 564. In some instances, the one ormore fixation members 564 may be positioned in one or more grooves or recesses formed in an outer surface of theshaft member 552. It can be appreciated that thefixation members 564 may be designed to provide a specific withdrawal force from a body structure into which the tack member may be inserted. For example, thefixation members 564 may be designed from a material having a selected modulus which allows the material to be compressed while inserted into a body structure. However, this material may also permit thefixation members 564 to impart a specific radially-outward force against the body structure while inserted into the body structure. This radially-outward force may correspond to the force required to remove thetack member 594 from the body structure. Thus, radial compression of thefixation members 564 may be necessary for insertion of thetack member 594 into a body structure (e.g., bone) and removal of thetack member 594 from the body structure (e.g., bone). The materials, number, geometry, spacing, etc. utilized for thefixation members 564 may be tailored to provide a particular "release" force corresponding to a maximum threshold force that a clinician may want to impart ontack member 564 to remove it from the body structure. -
Figure 12E illustrates anothertack member 694.Tack member 694 may include aproximal end region 640 and adistal end region 650. Thedistal end region 650 may includeshaft member 652 and atip member 654. Thetip member 654 may be positioned at the distal end of theshaft member 652. Additionally, in some examples thetack member 694 may include one or more radially extending portions positioned along theshaft member 652. Radially extended portions may be protuberances (e.g., continuous or discontinuous circumferential and/or helical flats, etc.) extending radially outward beyond the outer surface of theshaft member 652, for example. For instance,Figure 12E shows aradially extending portion 653A positioned along theshaft member 652 and extending radially outward from the outer surface ofshaft member 652. Additionally,Figure 12E shows a secondradially extending portion 653B positioned adjacent to and/or extending fromtip member 654. However, it is contemplated that thetack member 694 may include a single radially extending portion or more than two radially extending portions. For example, thetack member 694 may include 1, 2, 3, 4, 5, 6, 7, 8 or more radially extending portions. In some examples, the first radially enlarged portion 652A may be positionedadjacent tip member 654. - In some examples, the
proximal end region 640 of thetack member 694 may include avertical bore 655 extending inward from aproximal end surface 657 of thetack member 694. Thevertical bore 655 may extend along thelongitudinal axis 659 of thetack member 694. Additionally,Figure 12E illustrates the tether member 96 (discussed with respect toFigure 12A ) extending within thevertical bore 655. As shown inFigure 12E , thevertical bore 655 may include a profile which mirrors the shape of thetether member 96 extending within thevertical bore 655. It can further be appreciated that thetether member 96 may be attached to thetack member 694 via thevertical bore 655. In other words, thetether member 96 may be rigidly fixed to thetack member 694 within thevertical bore 655 via a variety of attachment techniques (e.g., welding, adhesive, crimping, swaging, etc.) The diameter of thetether member 96 is illustrated as being less than the diameter of thevertical bore 655, however, it is noted that upon securement of thetether member 96 withinvertical bore 655, thetether member 96 may substantially occupy thebore 655. -
Figure 12E illustrates that the first radially extendingportion 653A and the second radially extendingportion 653B may be spaced longitudinally away from one another along theshaft member 652 with a portion of theshaft 652 positioned therebetween. For example,Figure 12E shows the distance at which each of the first radially extendingportion 653A and the second radiallyenlarged portion 653B are spaced away from thedistal end 660 of thetip member 654. For example, "X5" depicts the distance at which the first radially extendingportion 653A is spaced away from thedistal end 660 of thetip member 654. In some examples, X5 may be between 0.090 inches and 0.175 inches, or may be between 0.115 inches and 0.150 inches, or may be about 0.127 inches, for example. Additionally, "X4" depicts the distance at which the second radially extendingportion 653B is spaced away from thedistal end 660 of thetip member 654. In some examples, X4 may be between 0.025 inches and 0.100 inches, or may be between 0.050 inches and 0.075 inches, or may be about 0.062 inches. - However, it is further contemplated that in some examples the first radially extending
portion 653A and the second radiallyenlarged portion 653B may be adjacent one another. In other words, it is contemplated that the first radially extendingportion 653A and the second radiallyenlarged portion 653B may be positioned directly adjacent one another. It is further contemplated that in some examples thetack member 694 may include more than two radially extending portions, some of which may be positioned away from other radially extending portions and/or some of which may be positioned directly adjacent other radially extending portions. - Additionally, the detailed view of
Figure 12E illustrates that the first radiallyenlarged portion 653A and/or the second radiallyenlarged portion 653B may include a rim orlip portion 651 having a radially extendingtip 655 which extends laterally away from the outer surface of theshaft member 652. Theradially extending portion 653A (including rim or lip portion 651) may have an outer diameter which is greater than the outer diameter of theshaft member 652. For example,Figure 12E shows the diameter of the rim orlip portion 651 extending radially outward from the surface of theshaft member 652 as "D2" and the diameter of theshaft member 652 as "Dj." In some examples, D2 may be between 0.035 inches and 0.100 inches, or may be between 0.050 inches and 0.075 inches, or may be about 0.070 inches. Further, in some examples, D1 may be between 0.010 inches and 0.075 inches, or may be between 0.025 inches and 0.060 inches, or may be about 0.044 inches. In some examples, the distance that a firstradially extending portion 653A and second radially extendingportion 653B extends away from the surface of theshaft member 652 may be different. For example, a more proximal radially extending portion may extend radially outward from the shaft member 652 a greater distance or a lesser distance than a more distal radially extending portion. In other examples (like those described above), the distance that a first radially extending portion and a second radially extending portion extends away from the surface of theshaft member 652 may be substantially equivalent. - It can be appreciated that the distance that radially extending
portions 653A/653B extend radially away from the surface of theshaft member 652 may correspond to the force required to retract thetack member 694 from a body structure into which thetack 694 may be inserted. It can further be appreciated that the shape, geometry, materials, etc. of thetack member 694 may be tailored to impart specific withdrawal forces from a body structure into which thetack member 694 may be inserted. - Further, in one
example tack member 94 may be the first portion ofdelivery system 40 that exists thedistal end 48 ofdelivery sheath 42 when theframe 46 anddelivery shaft 44 are advanced out of thedelivery sheath 42 upon deployment of thedelivery system 40. In some instances, as thedelivery sheath 42 is advanced through an insertion site toward a target site, the frame 46 (to whichimplant 12 is attached) and astationary tack member 94 may be fully housed within thelumen 84 ofdelivery sheath 48. Additionally, as thedelivery shaft 44 is advanced out thedistal end 48 of thedelivery sheath 44, thestationary tack member 94 may be driven directly into an adjacent structure (e.g., bone). - However, in other examples,
frame member 46 andimplant 12 may be positioned within delivery sheath 42 (depicted as dashed line) as shown inFigure 13A. Figure 13A shows frame member 46 (with implant 12) substantially aligned longitudinally withdelivery shaft 44 andtack member 94. In this example, thedistal portion 54 offrame 46 andimplant 12 may be located distal oftack member 94 withindelivery sheath 42, and thus the first portion ofdelivery system 40 that exits thedistal end 48 ofdelivery sheath 42 when theframe 46 anddelivery shaft 44 are advanced out of thedelivery sheath 42 upon deployment of thedelivery system 40. - In yet other examples, the
frame member 146 andimplant 112 may be positioned withindelivery sheath 42 as shown inFigure 13B . Further,Figure 13B shows frame member 146 (and implant 112) substantially aligned longitudinally withdelivery shaft 44 andtack member 94. In this example, the distal portion offrame 146 andimplant 112 may be located distal oftack member 94 withindelivery sheath 42, and thus the first portion of delivery system 140 that exits the distal end ofdelivery sheath 42 when theframe 146 anddelivery shaft 44 are advanced out of thedelivery sheath 42 upon deployment of thedelivery system 40. - Additionally,
Figure 13C illustrates thatimplant 112 may be rolled up and positioned betweenframe member 146 and thedelivery sheath 42. Further, it can be appreciated that when positioned indelivery sheath 42 as illustrated inFigure 13B ,implant 112 may wrap aroundframe member 146 withframe member 146 located radially inward ofimplant 112, and thereby extend along all or a portion of the inner surface ofdelivery sheath 42. Upon exiting the distal end ofdelivery sheath 42,implant 112 may unwrap to a configuration illustrated inFigure 10 andFigure 11 . - In other examples,
tack member 94 may translate (e.g., slide, move, etc.) along a longitudinal axis within a lumen (not shown) offirst connection member 90 ofconnection assembly 88. For example,Figure 14 showsexample deployment system 40 positioned adjacent an example target site.Figure 14 shows theproximal portion 52 of the frame 46 (along with implant 12) positioned adjacent thehumeral head 16. In this position, thedistal portion 54 of theframe 46 is positioned adjacent thetendon 24.Figure 14 further illustrates that thetack member 94 has not been advanced and/or extended out of thefirst connection member 90 ofconnection assembly 88 and driven into the humeral head. Rather, thetack member 94 remains positioned within the connection assembly 88 (e.g., positioned within first connection member 90). However, in some examples contemplated herein,tack member 94 may be advanced out of the distal portion ofdelivery shaft 44 and/orconnection assembly 88. In other words, thetack member 94 translates (e.g., slides, moves, etc.) relative toconnection assembly 88 and advances away from thedistal end 50 ofdelivery shaft 44. -
Figure 15 illustratestack member 94 being advanced out of thedistal portion 50 ofdelivery shaft 44 after delivery shaft 44 (along withframe 46 and implant 12) have been maneuvered and/or positioned adjacent an example target site. In some examples,Figure 15 may depict delivery system 40 (discussed with respect toFigures 7 and8 ) after thetack member 94 has been advanced out of thedistal end 50 of the delivery shaft 44 (e.g., advanced distally of first connection member 90) and into thehumeral head 16. As discussed above,tack member 94 may be advanced out of thedistal end 50 ofdelivery shaft 44 via the application of a force at the proximal end of thedelivery system 40 and/or actuation of an actuation mechanism to movetack member 94 relative tofirst connection member 90. In some instances, a handle component may be utilized to generate a force to advancetack member 94 along a longitudinal axis ofdelivery shaft 44 and exit thedistal end 50 ofdelivery shaft 44 distal offirst connection member 90. -
Figure 15A illustrates the anchoring mechanism of the example tack member 394 (discussed above). As discussed with respect toFigure 15 , in some examples the tack member 94 (of whichtack member 394 shown inFigure 15A is a variation) may be anchored into thehumeral head 16 of the humerus (a portion of which is shown inFigure 15A ). As shown inFigure 15A , thehumeral head 16 may include acortical shell 17 covering a layer ofsoft bone 19. The cortical shell may be referred to as "hard" bone.Figure 15A further illustrates that in some instances it may be desirable to advance thetack member 394 through the layer of cortical bone such that the first radiallyenlarged portion 356A and/or the second radially enlarged portion 357A is positioned beneath the cortical bone layer. In other words, thetack member 394 may be advanced into thehumeral head 16 such that the first radiallyenlarged portion 356A and/or the second radially enlarged portion 357A is positioned within the layer of soft bone, wherein the first radiallyenlarged portion 356A and/or the second radially enlarged portion 357A provide resistance to being pulled back through the underside of the cortical bone layer. In instances in which the first radiallyenlarged portion 356A and/or the second radially enlarged portion 357A are made of a compressible material, the first radiallyenlarged portion 356A and/or the second radially enlarged portion 357A may be compressed as the first radiallyenlarged portion 356A and/or the second radially enlarged portion 357A are passed through thecortical shell 17. It can be appreciated that the amount of resistance provided by the first radiallyenlarged portion 356A and/or the second radially enlarged portion 357A may depend on the specific size and geometry of the first radiallyenlarged portion 356A and/or the second radially enlarged portion 357A. - In some instances, once
tack member 94 has been anchored into a target site (as described above), it may be desirable to remove thedelivery shaft 44 to make room for additional instruments to be advanced adjacent the target site.Figure 16 illustrates removingdelivery shaft 44 from the target site (depicted by the arrow inFigure 16 ) while theframe 46 andimplant 12 remain anchored to thehumeral head 16 via thetack member 94. As discussed above,delivery shaft 44 may be detached fromframe 46 via uncoupling (e.g., detaching)second connection member 92 fromfirst connection member 90. - In some instances, it may be desirable to reengage
delivery shaft 44 after detachingsecond connection member 92 fromfirst connection member 90. For example, in some instances, the bone (e.g., humeral head) in whichtack member 94 is initially inserted may be abnormally soft or hard, and therefore, may require additional force to either maintain placement (e.g., if the bone is too soft) or to remove (e.g., if the bone is too hard). Therefore, a clinician may choose to reinsert and reengageshaft member 44 to frame 46 via re-couplingsecond connection member 92 tofirst connection member 90, such as afterimplant 12 has been attached to a target site via one or more bone and/or tendon staples, as described below. Alternatively,shaft member 44 may remain engaged to frame 46 while attachingimplant 12 to a target site via one or more bone and/or tendon staples, as described below. The clinician may then be able to apply additional force to frame 46 and/ortack member 92 when attachingimplant 12 to an example target site via one or more bone and/or tendon staples. - As discussed above,
delivery system 40 may include atether 96 directly or indirectly coupled toframe 46. It can be appreciated thattether 96 may remain attached to frame 46 (e.g., via first connection member 90) and extend to a location exterior of the patient through insertion site (i.e., incision) withdelivery shaft 44 detached fromframe 46 and removed from insertion site (i.e., incision) while additional instruments are advanced through the insertion site and to the target site. For example,Figure 17 shows a medical instrument 98 (e.g., implant stapler) positioned adjacent theproximal end 52 of theframe 46 andimplant 12. As discussed above and shown inFigure 17 ,tether 96 remains attached to frame 46 (e.g., via first connection member 90) and is positioned exterior of and alongside examplemedical instrument 98. Themedical instrument 98 may be used to attachimplant 12 to treatment site, such as with one or more, or a plurality of staples and/or sutures. - As discussed above, in some instances,
implant 12 may be affixed to a target site after which theframe 46 may be detached (and removed) from bothimplant 12 and the target site. For example, in some instances,implant 12 may be attached to a target site via one or more bone and/or tendon staples. The staples may be applied to the target site via a stapling instrument (e.g., medical instrument 98). - Further, in some instances, it may be beneficial to affix
implant 12 to the bone portion of the target site (e.g., humeral head 16) prior to affixing the implant to thetendon portion 24 of the target site. For example, it may be beneficial for a clinician to orient and/or position theframe 46 andimplant 12 in the location/arrangement shown inFigure 17 prior to affixing the implant to the target site. As shown inFigure 17 (and previously discussed) the implant is positioned such that theproximal portion 52 of theframe 46 andimplant 12 are positioned adjacent thehumeral head 16, while thedistal portion 54 is positioned adjacent thetendon 24. Once theframe 46 andimplant 12 have been placed appropriately, it may be desirable to utilize a stapling instrument to first insert staples along theproximal portion 52 of the implant (e.g., the portion of theimplant 12 positioned adjacent the bone) and into bone, followed by insertion of staples along the sides and distal portion ofimplant 12 and into tendon tissue. - It can be further appreciated that because the examples disclosed herein allow for the removal of the
delivery sheath 42 anddelivery shaft 44 prior to insertion of the stapling instrument, sufficient room exists to manipulate the stapling instrument in order to accurately place the staples along theproximal portion 52 of the implant adjacent thehumeral head 16. - Additionally, as discussed above, the
tack member 94 may anchor theframe 46 andimplant 12 in place (e.g., to the bone 16), thereby allowing a clinician to remove thedelivery shaft 44 without fear that the frame/implant 46/12 combination will change position prior to the insertion of staples into theimplant 12. - Once the
implant 12 has been sufficiently affixed to the target site, the clinician may detach theframe 46 from the implant 12 (within the body) and remove it from the body via the insertion site. For example,Figure 18 shows the detachment and removal of theframe 46 from the implant 12 (within the body) after the implant has been affixed (e.g., via staples) to the target site. In some instances, the clinician may detach and removeframe 46 from theimplant 12 and the body via application of a withdrawal force to theframe 46. The withdrawal force made be applied via thetether 96. For example, a clinician may pull on the tether 96 (the proximal end of which may be positioned outside of the body), thereby applying a withdrawal force to frame 46. Once the withdrawal force reaches a threshold level (as discussed above), theframe 46 will detach fromimplant 12. Further withdrawal of thetether 96 may be continued to pullframe 46 out of the body via the insertion site. - It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The disclosure's scope is, of course, defined in the language in which the appended claims are expressed.
Claims (14)
- An implant delivery system (40), the implant delivery system comprising:a delivery shaft (44) including a proximal portion, a distal portion and a lumen extending therebetween;a frame (46, 146, 246) detachably coupled to the distal portion of the delivery shaft; anda tack member (94, 394, 494, 594, 694) coupled to the frame;wherein the tack member includes a shaft (352, 452, 552, 652) having a circumferential surface characterised in that the tack includes one or more protrusions extending radially away from the circumferential surface.
- The implant delivery system of claim 1, wherein a distal end portion of the tack member includes a tapered region.
- The implant delivery system of claim 2, wherein a proximal end portion of the tack member includes a bore (355, 455, 555, 655) extending along a longitudinal axis (359, 459, 559, 659) of the tack member
- The implant delivery system of claim 3, wherein a distal end portion of a tether member (96) is secured within the bore of the tack member.
- The implant delivery system of any one of claims 1-4, wherein the one or more protrusions are configured to anchor the tack member beneath a layer of bone.
- The implant delivery system of claim 5, wherein the one or more protrusions includes a continuous circumferential flat extending radially outward beyond the circumferential surface of the shaft of the tack.
- The implant delivery system of claim 5, wherein the one or more protrusions includes a rim extending radially outward from the circumferential surface of the shaft of the tack and having a diameter of between 0.035 inches (0,889 mm) and 0.100 inches (2.54 mm).
- The implant delivery system of claims 1-4, wherein the tack comprises a plurality of protrusions, wherein the plurality of protrusions is spaced away from each other along the shaft of the tack.
- The implant delivery system of claim 8, wherein each of the plurality of protrusions includes a continuous circumferential flat extending radially outward beyond the circumferential surface of the shaft of the tack.
- The implant delivery system of claim 8, wherein each of the plurality of protrusions includes a rim extending radially outward from the circumferential surface of the shaft of the tack and having a diameter of between 0.035 inches (0.889 mm) and 0.100 inches (2.54 mm).
- The implant delivery system of claim 10, wherein the shaft of the tack has a diameter of between 0.010 inches (0.254 mm) and 0.075 inches (1.905 mm) between the plurality of protrusions.
- The implant delivery system of any one of claims 1-4, wherein the shaft of the tack is formed from a " first material and one or more fixation members disposed along the shaft of the tack are formed from a second material different from the first material.
- The implant delivery system of claim 12, wherein the one or more fixation members extend radially away from the circumferential surface of the shaft of the tack.
- The implant delivery system of claim 1, wherein the frame includes:a body portion (56, 156);a plurality of attachment arms (64, 164, 264) extending away from the body portion, wherein each attachment arm includes one or more openings extending through a thickness of the attachment arm;an attachment member (76, 176, 276) threaded through the one or more openings of each attachment arm; anda locking member (198, 298) molded onto a distal portion of each attachment arm and covering the associated attachment member and one or more openings to secure the attachment member to the attachment arm.
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EP4103069A1 (en) | 2020-02-11 | 2022-12-21 | Embody Inc. | Surgical anchoring device, deployment device, and method of use |
CN115297805A (en) | 2020-02-11 | 2022-11-04 | 恩博迪股份有限公司 | Implant delivery device |
EP4228518A1 (en) * | 2020-12-16 | 2023-08-23 | Smith & Nephew, Inc. | Medical implant delivery system for sheet-like tissue implant |
WO2022235683A1 (en) * | 2021-05-04 | 2022-11-10 | Smith & Nephew, Inc. | Medical implant delivery system |
US20240138868A1 (en) | 2022-10-28 | 2024-05-02 | Expand Medical Ltd. | Implant delivery device |
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2018
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CN110225726A (en) | 2019-09-10 |
WO2019113292A1 (en) | 2019-06-13 |
US20210052366A1 (en) | 2021-02-25 |
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